Bone anchor installer and method of use

ABSTRACT

Systems, apparatuses and methods for securing tissue to bone using a bone anchoring system are described. Methods and apparatuses may allow transformation between locked and unlocked states, thereby allowing adjustment of the tension in the suture. The apparatus and/or methods may allow unidirectional movement of a suture, while preventing slippage or movement of the suture and tissue in the opposite direction. Ends of a suture may be individually tensioned to adjust positioning of a tissue with respect to a bone.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

The present application claims the right of priority under 35 U.S.C.§120 to U.S. application Ser. No. 11/726,736, filed Mar. 22, 2007. Thepresent application claims the right of priority under 35 U.S.C. §119 toU.S. provisional application No. 60/784,679, filed Mar. 22, 2006. U.S.provisional application No. 60/784,679 is commonly owned with thepresent application and the entire contents thereof are hereby expresslyincorporated by reference in its entirety as though fully set forthherein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to systems, methods and apparatus forsecuring tissue to bone. More particularly, the invention relates toapparatus and methods for facilitating the attachment of tissue to boneusing a bone anchoring system. The present invention further relates toa suture passer instruments for retrieving a suture loop.

2. Description of the Related Art

Many attempts have been made to provide devices that allow thearthroscopic securing of torn tissue to a human bone. For example,numerous devices have been designed to allow a torn rotator cuff to besecured to a humeral head of the shoulder.

Typically, in a first step, a hole is drilled into the bone underarthroscopic visualization. A length of a suture length is threadedthrough a portion of a tissue, and then coupled to a bone anchorconfigured. One or more sutures may be manipulated outside of thearthroscopic site.

Once the suture is coupled between the tissue and the bone anchor, thebone anchor may be inserted into the hole. The bone anchor may beconfigured to lock itself within the hole in the bone upon deploymenttherein.

Several means for securing the bone anchor within the hole of a bone areknown in the art.

Once the bone anchor is secured within the hole in the bone, one or bothends of the suture may be tensioned to approximate the positioning ofthe tissue with respect to the bone. Once the tissue is positioned asdesired, the suture may be locked in place to maintain the tension inthe suture. The free end or ends of the suture may be clipped underarthroscopic visualization to complete the procedure.

An example of a previously known method and apparatus for attachingtissue to bone is described in U.S. Pat. No. 6,585,730 to Foerster,which is incorporated by reference herein. Foerster describes devicesand methods for securing sutures to a bone anchor without therequirement of knot tying. In Foerster, suture legs, after having beenplaced into soft tissues to be anchored to bone, are threaded throughthe anchor and then through a floating wedge block located at the distalend of the anchor. The wedge block is configured such that it has ahollow lumen through the center, and a conically tapered outer surface.The sutures are passed back around the outside of the wedge block suchthat they rest on the conical surface. They are then re-threaded in theopposite direction back through the anchor, exiting the anchor at theproximal end thereof. The anchor is then inserted into the bone, andsecured. When tension is placed on the legs of the suture passing backout of the anchor, the suture is drawn through the hollow center lumen,around the distal end of the wedge block, and back out of the anchor.This tension tends to cause the wedge block to force its way back upinto the anchor body, and a means to prevent this may be employed. Suchmeans may include any structure that selectively holds the wedge blockseparate from the anchor body.

At this juncture, by pulling on the suture legs, any slack in thesutures is removed, and the soft tissues are drawn toward the anchor.When the soft tissues are in the desired orientation, relative to thebone to which they are to be attached, the structure holding the wedgeblock is removed, and the back tension on the sutures pulls the wedgeblock into the matching taper in the anchor body, maintaining thecompressive force on the suture legs.

Another previously known knotless suture anchor is described in U.S.Pat. No. 6,692,516 to West et al. (“West”), which is incorporated byreference herein. West describes a knotless suture anchor and method forknotlessly securing. The suture anchor has a deformable portion forengaging with a wall of a borehole in a first tissue member, a shaft forproviding a force to the deformable portion to deform the deformableportion to cause the deformable portion to engage the wall of theborehole, a suture retaining portion in at least one of the deformableportion and the shaft for retaining two suture portions in the retainingportion with a loop formed between the two suture portions. The loop isadapted to traverse a second tissue member to be attached to the firsttissue member. Application of the force to deform the deformable portioncauses engagement of the deformable portion with the borehole to securethe suture anchor to the first tissue and clamping of at least one ofthe two suture portions in the suture retaining portion thereby tosecure the suture forming the loop in the suture retaining portion andsecure the second tissue to the suture anchor.

Systems, apparatus and methods are desired for securing tissue to bonethat allow direct tactile feedback of the tension in the suture betweenthe tissue and bone. During securing tissue to bone, it is desired to beable to adjust positioning of the tissue with respect to the bone. Insecuring the tissue to bone, the suture may be locked in place withouttying a knot.

Endoscopic suturing techniques and instruments have been developed tofacilitate the suturing of tissue during endoscopic surgical procedures.Access to a surgical work site within a patient's body is normallyprovided through one or more portals formed directly in the patient'sbody or through one or more cannulas inserted into the patient's bodythrough small incisions. A chosen surgical procedure is carried out by asurgeon through the use of elongated instruments inserted through thesecannulas and it often becomes necessary to suture selected tissue at thesurgical work site.

The arthroscopic work site is typically accessible only through a smallportal or cannula. Since it is very difficult to tie sutures within thebody, various devices and techniques have been developed to enable thesurgeon to tie sutures endoscopically. For example, some proceduresenable the surgeon to pass a suture through the target tissue and form asurgical knot extracorporeally and then move the knot with a knot pusherthrough the portal or cannula into position adjacent the desired tissueto be sutured. Formation of the knot requires the surgeon to manuallyretrieve and tie a knot on the suture after the suture is threadedthrough the tissue(s). This procedure is often tedious andtime-consuming. The procedure further requires that a mechanical meansof retrieving the suture be provided. Most devices require the use of aseparate tool to grab onto and retrieve the suture, thereby furtherreducing the working space and adding risk of contamination, or leadingto a tendency for the suture to deform or collapse suture is manuallyretrieved. In addition, tying the knot in this manner is particularlydifficult during endoscopic surgeries, where the visual field for thesurgeon is severely limited by the narrow surgical area. As a result ofthese setbacks, there is a need for an improved method of retrieving asuture, as well as for surgical devices that will facilitate suchmethod.

SUMMARY OF THE INVENTION

In some embodiments, a bone anchor installer system includes aninstaller tool. The installer tool may include a handle portion coupledto a loader portion. The loader portion may be configured such that abone anchor is couplable to at least a portion thereof.

In an embodiment, a bone anchor installer system may include a boneanchor coupled to the distal end of the installer tool. The system mayfurther include a means of tethering a bone anchor coupled to the distalend of the installer tool. The tethering means may be accessible to asurgeon during use.

In an embodiment, a bone anchor installer system may include an anchorholder removably coupled to the distal end of the loader portion. Theanchor holder may include a first portion coupled to a second portion,said first and second portions defining a cavity sized to accept thedistal end of the loader portion having a bone anchor is coupledthereto. An anchor holder may further include a means of uncoupling theanchor holder from the distal end of the installer tool.

In an embodiment, a bone anchor installer system may include a suturepuller coupled to the anchor holder such that coupling a suture to abone anchor during use is facilitated. A suture puller may include aproximal end configured to allow an operator to pull the suture pullerthrough the anchor holder. A suture puller may include a centralportion. The central portion may be engaged with the anchor holder and abone anchor residing therein such that pulling the proximal end of thesuture holder couples one or more suture ends to the bone anchor. Asuture puller may include a distal end. The distal end of a suturepuller may be couplable to one or more sutures.

In an embodiment, an installer system may include a cannula configuredsuch that at least a portion of the installer having a bone anchorcoupled thereto is deliverable to a surgical site during use.

In some embodiments, an installer system may include an installer toolthat includes a handle portion and a loader portion. The loader portionmay have a proximal end and a distal end. The proximal end may becoupled to the handle portion. The distal end may be configured suchthat a bone anchor is couplable thereto. A channel may extend from thehandle portion to the distal end of the loader portion.

In an embodiment, an installer system may include a means of tethering abone anchor to the distal end of the loader portion. The tethering meansmay be positioned within the channel of the installer tool. At least aportion of the tethering means may be accessible to a surgeon duringuse.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects and advantages of the invention will become apparent uponreading the following detailed description and upon reference to theaccompanying drawings in which:

FIG. 1 is a schematic of a bone and tissue interface;

FIG. 2A is a perspective front view of an embodiment of a bone anchor;

FIG. 2B is a perspective side view of the bone anchor along line A-A ofFIG. 2A;

FIG. 2C is a cross-sectional view of the bond anchor depicted in FIG.2A;

FIG. 3A is a perspective side view of bone anchor;

FIG. 3B is exploded side view along line B-B of FIG. 3A;

FIG. 3C is perspective top view of the bone anchor depicted in 3A;

FIG. 3D is a perspective view of the top of the bond anchor depicted in3C in an open state;

FIG. 3E is a cross-sectional view of the bone anchor depicted in FIG.3A;

FIG. 4A is a cross-sectional view of an embodiment of an apparatus thatincludes bone anchor member and a plug portion;

FIG. 4B is a perspective side view of the plug portion depicted in FIG.4A;

FIG. 4C is a perspective side view of an opposing side of the plugportion depicted in FIG. 4A;

FIG. 5A is a cross-sectional view of an embodiment of a bone anchor thatincludes bone anchor member and a plug portion;

FIG. 5B is a perspective side view of the plug portion depicted in FIG.SA;

FIG. 5C is a perspective side view of an opposing side of the plugportion depicted in FIG. SA;

FIG. 6A is a perspective side view of an embodiment of plug portion in aclosed state;

FIG. 6B is a perspective side view of the plug portion depicted in FIG.6A in a partially open state;

FIG. 6C is perspective a top view of the plug portion depicted in FIG.6B;

FIG. 7 is perspective side view of an embodiment of a plug portion in apartially open state;

FIG. 8A is a perspective side view of an embodiment of a plug;

FIG. 8B is a perspective side view of the plug depicted in FIG. 8A in apartially open state;

FIG. 8C is a perspective top view plug depicted in FIG. 8A in a fullyopen state;

FIG. 9 is a cross-sectional view of an embodiment of a bond anchorhaving at least one adhesive delivery channel;

FIG. 1OA is a cross-sectional view of a bone anchor that includes a boneanchor member and a plug portion;

FIG. 1OB is a perspective view of the bone anchor of FIG. 1OA positionedin a hole of a bone;

FIG. 11 is a cross-sectional view of an embodiment of a bone anchor thatincludes a bone anchor member and a plug portion;

FIG. 12 is perspective side view of an embodiment of a bone anchorpositioned in a bone with two openings;

FIG. 13A is a cross-sectional view of an embodiment of a bone anchorthat includes a bone anchor member and a plug portion;

FIGS. 13B and 13C are illustrations of usage of the bone anchor depictedin FIG. 13A;

FIG. 14 is a cross-sectional view of an embodiment of an apparatus thatincludes a bone anchor member with a spring element;

FIG. 15A is perspective top view of top view of an embodiment of a boneanchor that includes a bone anchor and a plug portion;

FIG. 15B is a cross-sectional view of the bone anchor depicted in FIG.15 A along line 15C-15C;

FIG. 15C is perspective top view of the bone anchor of FIG. 15A in alocked state;

FIG. 16 is a perspective view illustrating use of a suture in connectionwith the bone anchor depicted in FIGS. 15A-15C;

FIGS. 17A and 17B are cross-sectional views of embodiments of a boneanchor in an unlocked state and a locked state, respectively;

FIGS. 18A and 18B are cross-sectional views of embodiments of a boneanchor in an unlocked state and a locked state, respectively;

FIGS. 19A and 19B are cross-sectional views of an alternative embodimentof the bone anchor depicted in FIGS. 17 A and 17B;

FIGS. 20A and 20B are, respectively, a cross-sectional view and aperspective side view of an embodiment of an unlocked state of a boneanchor that includes a bone anchor member and a plug portion;

FIGS. 21A and 21B are, respectively, a cross-sectional view and aperspective side view depicted in FIGS. 20A and 20B in a locked state;

FIG. 22A is a cross-sectional view of an embodiment of a bone anchorthat includes a bone anchor member and a plug portion;

FIG. 22B is a cross-sectional view of the plug portion inserted in thebone anchor member depicted in FIG. 22A;

FIG. 23A is a cross-sectional view of an embodiment of the plug depictedin FIGS. 22A and 22B;

FIG. 23B is a perspective side view of the plug depicted in FIG. 23A;

FIG. 23C is a perspective bottom view of the plug depicted in FIG. 23A;

FIG. 24A is a cross-sectional view of an embodiment of a bone anchorthat includes a bone anchor member and a plug portion;

FIG. 24B is a cross-sectional view of a plug portion inserted into thebone anchor member depicted in FIG. 24A;

FIGS. 25A and 25B are illustrations of the bone anchor depicted in FIGS.24A and 24B employing two sutures;

FIG. 26A depicts an embodiment of a bone anchor;

FIG. 26B is a cross-sectional view depicting a suture locking mechanismof the bone anchor depicted in FIG. 26A in a closed position;

FIG. 26C is a cross-sectional view depicting the suture lockingmechanism depicted in FIG. 26B in an open position;

FIG. 26D is an exploded view of the bone anchor depicted in FIG. 26A;

FIG. 27 A is a perspective view of an embodiment of a bone anchor;

FIG. 27B is a cross-sectional view of the bone anchor depicted in FIG.27 A;

FIG. 27C is an exploded view of the bone anchor depicted in FIG. 27A;

FIG. 28A is a perspective view of an embodiment of a bone anchor;

FIGS. 28B and 28C are cross-sectional views of the bone anchor depictedin FIG. 28A with release elements in the locked and unlocked positions,respectively;

FIG. 28D is an exploded view of the bone anchor depicted in FIG. 28A;

FIG. 29A depicts an embodiment of a bone anchor having a cam with asuture positioned between the cam and a surface at the distal end of thebone anchor;

FIG. 29B is a cross-sectional view of the embodiment depicted in FIG.29A;

FIG. 29C is a perspective front view of the bone anchor depicted in FIG.29A;

FIG. 29D is an exploded view of the bone anchor and suture depicted inFIG. 29A;

FIG. 30A depicts an embodiment of a bone anchor having a suture lockingassembly;

FIG. 30B is a cross-sectional view of the bone anchor depicted in FIG.30A;

FIG. 30C is a perspective side view of the bone anchor depicted in FIG.30A;

FIG. 30D is an exploded view of the bone anchor depicted in FIG. 30A;

FIG. 31A depicts an alternate embodiment of a bone anchor having asuture locking assembly;

FIG. 31B is a cross-sectional view of the bone anchor depicted in FIG.31A;

FIG. 31C is an exploded view of the bone anchor depicted in FIG. 31A;

FIG. 32A depicts a further alternate embodiment of a bone anchor havinga suture locking assembly;

FIG. 32B depicts a cross-sectional view of the bone anchor of FIG. 32A;

FIG. 32C depicts an exploded view of the bone anchor of FIG. 32A;

FIG. 33 depicts an alternate embodiment of a bone anchor having a fixedsuture coupling;

FIG. 34 is an alternate embodiment of that shown in FIG. 33;

FIG. 35A-FIG. 35G depict a variety of alternate bone anchor embodiments;

FIG. 36 depicts an embodiment of a bone anchor installer for use in abone anchor system;

FIG. 37A is a schematic representation of an anchor holder according toan embodiment of a bone anchor installer;

FIG. 37B is an exploded view of the anchor holder depicted in FIG. 37A;

FIG. 38A is a side sectional view of an anchor holder according to anembodiment;

FIG. 38B is an oblique view of the anchor holder depicted in FIG. 38A;

FIG. 39A is a depiction of a bone anchor installer according to anembodiment;

FIG. 39B is an enlarged view showing the anchor holder at the distal endof the bone anchor installer depicted in FIG. 39A;

FIG. 40A-40F depict a sequence of steps to use the bone anchor installerdepicted in FIG. 39A;

FIG. 41A depicts an anchor installer according to alternate embodiment;

FIG. 41B shows the distal end of the anchor installer depicted in FIG.461 with one half of the anchor holder removed;

FIG. 42A shows the component forming the anchor loader portion of theinstaller shown in FIG. 41A;

FIG. 42B shows the anchor loader FIG. 42A in its assembled state with abone anchor coupled to the distal end thereof by a tethering means;

FIG. 42C is an enlarged view of the distal end of the loader and boneanchor tethered thereto depicted in

FIG. 42B;

FIG. 42D is an enlarged view of the proximal end of the loader andtethering means shown in FIG. 42B;

FIG. 43 is a schematic depiction of a suture passer device according toan embodiment;

FIGS. 44A through 44E depict a sequence of steps to operate the distalend of the suture passer depicted in FIG. 43;

FIGS. 45A through 45D are schematic depictions of the proximal anddistal ends of the suture passer depicted in FIG. 43 in the retracted(FIG. 45A and FIG. 45B) and engaged (FIG. 45C and FIG. 45D) states,respectively.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof are shown by way ofexample in the drawings and will herein be described in detail. Itshould be understood, however, that the drawing and detailed descriptionthereto are not intended to limit the invention to the particular formdisclosed, but on the contrary, the intention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the present invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 is an illustrative schematic of a bone and tissue interface.Tissue T has a torn end and it is desirable to secure the torn end to asection of bone B. In a first step, hole H having diameter d_(H) may bedrilled in bone B, as depicted, using generally known bone drillingtechniques.

Bone anchor member 20 may secure tissue T to bone B. Bone anchor member20 may be used in conjunction with a length of suture 30. Suture 30 hasfirst end 32 a and second end 32 b. Ends 32 a, 32 b may be coupled tobone anchor member 20. A central region of suture 30 forms loop 34. Loop34 may be threaded through a section of tissue T near the torn end ofthe tissue using generally known threading techniques. In embodimentsdescribed herein tissue, hole, and bone refer to T, H, and B,respectively, as described in FIG. 1.

FIG. 2A is a perspective front view of an embodiment of a bone anchor.FIG. 2B is a perspective side view of the bone anchor along line A-Ashown in FIG. 2A. FIG. 2C is a cross-sectional view of the bond anchordepicted in FIG. 2A. Bone anchor member 20 has proximal region 22 anddistal region 24, as depicted in FIG. 2A. Bone anchor member 20 includesa plurality of cleated members 42. Cleated members 42 may be formed onor attached to an exterior surface of bone anchor member 20. Cleatedmembers 42 may secure bone anchor member 20 within a hole of a bone. Insome embodiments, bone anchor member 20 may include radially expandablemembers. Radially expandable members may embed into bone to secure thebone anchor member to the bone. In some embodiments, bone anchor member20 may include threaded exterior members. Threaded exterior members mayscrew into surrounding bone to secure the bone anchor member to thebone.

Referring to FIGS. 2B-2C, bone anchor member 20 includes first guidechannel 50 and second guide channel 52. Guide channels 50, 52 are formedwithin opposing surfaces of bone anchor member 20. Guide channels 50, 52are configured to accommodate regions of suture 30, so that the sutureregions do not extend outside of the confines of the guide channels whenin use.

Bone anchor member 20 includes first passage 60 and second passage 70.Passages 60, 70 extend laterally through a main body of bone anchormember 20, as depicted in FIG. 2C. Passage 60 communicates with firstguide channel 50 via opening 61, and further communicates with guidechannel 52 via opening 62. Similarly, passage 70 communicates with guidechannel 50 via opening 71, and further communicates with guide channel52 via opening 72.

Passage 60 is shown disposed proximal to second passage 70, i.e., thepassage 60 is closer to proximal region 22 of bone anchor member 20.However, as will be apparent to one skilled in the art, the passagesalso may be disposed adjacent one another, or otherwise positioned, toachieve the objects of the present invention.

Passages 60, 70 include at least one cleated member 74. Cleated member74 includes angled sections 75 and substantially orthogonal sections 76.Orthogonal sections 76 are disposed adjacent one another, therebyforming a cleated shape, as shown in FIG. 2C. Angled sections 75 areangled towards opening 62 of passage 60 and opening 72 of passage 70, asshown in FIG. 2C. In some embodiments, cleated passages 60, 70 areconfigured to permit one-way movement of first suture end 32 a andsecond suture end 32 b. For example, when suture end 32 a is pulled in aproximal direction, angled sections 75 allow movement of the suture endin the proximal direction, while inhibiting distally advancement ofsuture end 32 a within passage 60.

In certain embodiments, an outer diameter of suture 30 may be slightlylarger than an inner diameter of cleated passages 60 and 70. Therefore,suture ends 32 a and 32 b can pass through cleated passages 60 and 70 ina proximal direction with relatively little resistance while the sutureholds significantly greater force in the distal direction.

In one embodiment, a method for coupling suture 30 between tissue T andbone anchor member 20, a central region of suture 30 can be loopedthrough tissue T first, such that free ends 32 a and 32 b extend fromthe tissue. Free end 32 a is then threaded through one-way cleatedpassage 60 in a proximal direction, while free end 32 b is threadedthrough one-way cleated passage 70, also in a proximal direction.

As will be apparent to one skilled in the art, suture 30 may be coupledbetween tissue T and bone anchor member 20 using other threadingtechniques, so long as the suture ultimately is situated in a mannerdepicted in FIG. 2C.

First end 32 a of suture 30 is disposed through first passage 60, thentransitioned into loop portion 34 a. Loop portion 34 a transitions intoloop portion 34 b, forming loop 34 therebetween, which is coupled totissue T. Loop portion 34 b transitions into second end 32 b, which isdisposed through passage 70, as shown in FIG. 2C. Accordingly, first andsecond ends 32 a, 32 b of suture 30 may be independently manipulated forpurposes described herein below.

After suture 30 is coupled to bone anchor member 20 and a tissue, boneanchor member 20 is distally advanced into a hole of a bone underarthroscopic guidance. Exterior cleated members 42 of bone anchor member20 allow the bone anchor member to be advanced distally within the bonehole when an appropriate force is applied, but exterior cleated members42 inhibit proximal movement of bone anchor member 20 to provide asecure anchor within the bone.

Pulling one or both of suture ends 32 a and 32 b proximally throughcleated passages 60 and 70 may approximate the positioning of the tissuewith respect to the bone. The use of two separate passages allows thesurgeon to tension each end of the suture independently, which is oftendesirable when tissue is torn irregularly.

Further, the use of a plurality of cleated passages 60 70 permitsincremental tensioning of first and second suture ends 32 a, 32 b. Thisallows incremental adjustment during positioning of the tissue, usingtactile feedback as a guide. Once a desired tension is achieved,retraction of the suture ends is stopped, and the suture isautomatically locked in place. Thus, there is no need to tie a knot.

In some embodiments, guide channels 50 and 52 permit the retraction ofsuture ends 32 a, 32 b when bone anchor member 20 is secured within ahole of the bone by providing a clearance between the bone anchor memberand the bone itself.

Alternatively, suture 30 may be coupled to bone anchor member 20 usingtechniques described herein below with respect to FIGS. 3A-3E or FIGS.6-8. These techniques allow the suture to be coupled to bone anchormember 20 without the need to thread free ends 32 a and 32 b throughpassages 60 and 70.

FIGS. 3A-3E shows a further embodiment of bone anchor 20′. Bone anchor20′ includes a first mating portion 22 a and a second mating portion 22b. In some embodiments, mating portions 22 a, 22 b are substantiallysymmetrical, except as noted below.

Turning to FIG. 3B, mating portion 22 a includes cleated passage portion60 a and cleated passage portion 70 a. Mating portion 22 b includescleated passage portion 60 b and cleated passage portion 70 b. Whenassembled state as shown in FIG. 3A, cleated passage portion 60 a andcleated passage portion 60 b form cleated passage 60′, while cleatedpassage portions 70 a and cleated passage portion 70 b form cleatedpassage 70′.

Guide channel portions 50 a of mating portion 22 a and guide channel 50b of mating portion 22 b form guide channel 50′ in the assembled stateas depicted in FIGS. 3A and 3C. Guide channel portion 52 a of matingportion 22 a and guide channel portion 52 b of mating portion 52 b formguide channel 52′ in the assembled state as depicted in FIG. 3D.

Mating portion 22 a includes at least one mating pocket 59, as depictedin FIG. 3E. Mating portion 22 b includes at least one protrusion 55,which is configured to securely engage a corresponding pocket 59 in theassembled state of FIGS. 3A and 3C.

In a preferred embodiment, protrusion 55 includes ledge 57, as shown indetail “B” of FIG. 3D. Optionally, mating pocket 59 may include acomplementary recess having a slightly larger diameter (not shown),which is configured to receive ledge 57. In this manner, ledge 57 ofprotrusion 55 may snap into engagement with the larger diameter recessof pocket 59, thereby securing mating portions 22 a, 22 b.

During use, a first suture end may be positioned in cleated passageportion 60 a, and a second suture end positioned in cleated passageportion 70 a of FIG. 3E. Next, mating portion 22 b is secured to matingportion 22 a, (e.g., using a snap-lock engagement described abovebetween protrusion 55 and pocket 59).

The first and second suture ends are disposed through cleated passages60, 70. Using the bone anchor describe in FIGS. 3A-3E, threading thesuture ends through cleated passages 60 and 70 is not necessary, therebyincreasing the speed and ease of use of the device.

An alternate embodiment of bone anchor 100 is described in FIGS. 4A-4C.FIG. 4A is a cross-sectional view of an embodiment of a bone anchor thatincludes bone anchor member and a plug portion. FIG. 4B is a side viewof the plug portion depicted in FIG. 4A. FIG. 4C is a side view of anopposing side of the plug portion depicted in FIG. 4A.

Referring to FIG. 4A, bone anchor 100 includes bone anchor member 102and plug portion 110. Bone anchor member 102 includes main body 103having bore 104 disposed therein. Main body 103 may include cleatedmembers 106 disposed on the outer surface thereof. The shape anddimensions of cleated members 106 is not limited to that depicted inFIG. 4A. For example, cleated members 106 may be shaped substantiallysimilar to the cleated members 42 of bone anchor member 20. Cleatedmembers 106 are configured to insert into a hole of a bone using africtional force fit,

During use, after bone anchor member 102 is secured in the hole, plugportion 110 may be inserted into bore 104 of bone anchor member 102.Plug portion 110 may include cleated members 116 on the outer surfacethereof. Cleated members 116 may be configured to permit the advancementof plug portion into bore 104 and allow plug portion 110 to engage andfrictionally grip inner wall 105, thereby securing the plug portion 100to bone anchor member 102.

Referring to FIGS. 4B and 4C, plug portion 110 includes first and secondpassages 118 and 120. First and second suture ends 32 a and 32 b may becoupled to plug portion 110 of apparatus 100 in a manner similar to thatdescribed in FIG. 2C. First end 32 a of suture 30 is disposed throughfirst passage 118. After exiting through first passage 118, first end 32a then transitions into loop portion 34 a, forms loop 34, andtransitions into loop portion 34 b (e.g., as shown in FIGS. 2A-2C). Loopportion 34 b transitions into second end 32 b, which extends throughsecond passage 120.

Alternatively, suture 30 may be coupled to plug portion 110 usingtechniques described herein below with respect to FIGS. 6-8. Thesetechniques allow the suture to be coupled to plug portion 110 withoutthe need to thread free ends 32 a and 32 b through passages 118 and 120,as set forth below.

If desired, passages 118 and 120 of FIGS. 4A-4C may include cleatedmembers 74, as described hereinabove with respect to FIG. 2C. If cleatedmembers 74 are employed, then tissue may be secured to a bone (e.g., seeFIG. 1) by individually tensioning first and second ends 32 a, 32 b ofsuture 30, as described hereinabove.

Plug portion 110 preferably includes one or more guide channels 125disposed in a lateral surface of plug body 113. Guide channel 125preferably is substantially similar to guide channels 50 and 52 of FIG.2C. In FIG. 4C, guide channel 125 is configured to permit retraction offirst and second suture ends 32 a and 32 b when plug portion 110 issecured within bore 104 by providing a clearance between the plugportion and the bone anchor member.

Alternatively, passages 118 and 120 may be substantially smoothpassages, such that cleated members 74 are not employed. In this case,passages 118 and 120 permit substantially unimpeded movement of suture30 through the passages. In operation, suture ends 32 a and 32 b may beindividually tensioned prior to insertion of plug portion 110 into boneanchor member 102. When the tissue has been appropriately secured to thebone, plug portion 110 is then forced into bore 104 of bone anchormember 102. This causes suture ends 32 a and 32 b to be sandwichedbetween plug portion 110 and bone anchor member 102 when guide channels125 are not present. Accordingly, the suture is secured between the twoportions using a force fit.

FIGS. 5A-5C show a further embodiment of a bone anchor apparatus. Boneanchor 140 may include bone anchor member 142 and plug portion a 150 asshown in FIG. 5A. FIG. 5B is a side view of the plug portion depicted inFIG. 5A. FIG. 5C is a side view of an opposing side of the plug portiondepicted in FIG. 5A.

Referring to FIG. 5A, apparatus 140 includes bone anchor member 142 andplug portion 150. Bone anchor member 142 includes main body 143 havingbore 144 disposed therein. Main body 143 may include exterior cleatedmembers 146 and interior cleated members 145 disposed on the innersurface of bore 144. Exterior cleated members 146 are configured toinsert into a hole of a bone (e.g., see FIG. 1) using a force fit, asdescribed in earlier embodiments above.

Plug portion 150 includes main body 153. In an embodiment, main body 153may be substantially cylindrical in shape. In an embodiment, theexterior surface 156 of main body 153 may be substantially smooth. Mainbody 153 may include taper 157 at the distal end thereof.

Suture 30 having first and second ends 32 a, 32 b is coupled to plugportion 150. A method of coupling is described herein below with respectto FIGS. 6-8.

In operation, bone anchor member 142 is advanced into a hole of a bone(e.g., see FIG. 1). Exterior cleated members 146 of bone anchor member142 permit one-way movement of the bone anchor member into the hole.

Plug portion 150 may be inserted into bore 144 of bone anchor member142. An outer diameter of exterior surface 156 of plug portion 150 maybe slightly larger than an inner diameter of bore 144. Accordingly, whenplug portion 150 is urged distally, a force fit is achieved to secureplug portion 150 within the bore of bone anchor member 142.

Taper 157 of plug portion 150 facilitates the distal advancement of theplug portion with respect to bone anchor member 142. Interior cleatedmembers 145 are configured to permit advancement of plug portion 110into bore 144 in a distal direction only.

First and second suture ends 32 a and 32 b may be coupled to plugportion 150 in a manner described hereinabove with respect to FIGS.4A-4C. Specifically, first end 32 a of suture 30 is disposed throughfirst passage 158, and forms a loop that is threaded through a tissue.Second end 32 b of suture 30 extends through second passage 160.

First and second passages 158, 160 may include cleated members 74 (seeFIG. 2C). If cleated members 74 are employed, then tissue may be securedto the bone by individually tensioning first and second ends 32 a, 32 bof suture 30. Cleated members 74 permit incremental tensioning of eachsuture end, and serve to lock the suture ends within their respectivepassages 158 and 160, as generally set forth hereinabove with respect toFIG. 2C.

Plug portion 150 includes one or more guide channels 165 disposed in alateral surface of plug body 153, as shown in FIG. 5C. Guide channel 165is configured to permit retraction of first and second suture ends 32 a,32 b when plug portion 150 is secured within bore 144. In someembodiments guide channel 165 is substantially similar to guide channel50 of FIG. 2C.

Alternatively, passages 158, 160 may be smooth passages, such thatcleated members 74 are not employed and guide channels 165 are notpresent. In some embodiments, passages 158,160 may be substantiallysmooth. During use, suture ends 32 a, 32 b may be individually tensionedprior to insertion of plug portion 150 into bone anchor member 142. Whentissue is appropriately secured to the bone, then plug portion 150 isforced into bore 144 of bone anchor member 142. This causes suture ends32 a, 32 b to be sandwiched between plug portion 150 and bone anchormember 142. Accordingly, the suture is secured between the two portionsusing a force fit.

Further embodiments of a plug portion are described in FIGS. 6A-6C. Theplug portion may be used in bone anchors depicted in FIG. 4A-4C. FIG. 6Ais a side view of an embodiment of plug portion in a closed state. FIG.6B is a side view of the plug portion depicted in FIG. 6A in a partiallyopen state. FIG. 6C is a top view of the plug portion depicted in FIG.6B.

Plug portion 110′ includes first and second plug portions 110 a, 110 b,which are coupled together using binge member 115. Hinge member 115 maybe integral to first and second plug portions 110 a, 110 b, or the bingemember may be a third element that couples two distinct portionstogether.

Hinge member 115 permits plug portion 110′ to transition between aclosed state, as shown in FIG. 6A, and a partially or fully open state,as depicted in FIGS. 6B-6C, respectively. In the open states of FIGS.6B-6C, a first suture end may be positioned (e.g., quickly positioned bya physician) in passage 118 a and a second suture end positioned inpassage 120 a. Alternatively, the positioning of the suture ends may bereversed (e.g., first and second suture ends may be placed in passages120 b and 1118 b, respectively).

With the suture ends in place, plug portion 110′ may be transformed intoa closed state, depicted in FIG. 6A, by rotating first and second plugportions 110 a, 110 b together. In the closed state, first and secondplug portions 110 a, 110 b form first and second passages 118′, 120′.With the sutures ends disposed in their respective passages, theapparatus may be actuated to secure tissue to bone.

As will be apparent to one skilled in the art, hinge member 115 servesto ensure proper alignment of first and second plug portions 110 a, 110b in the closed state. If desired, a securing means, such as protrusion55 and pocket 59 of FIGS. 3A-3E, may be employed to secure plug portions110 a and 110 b. Further, as will be apparent to one skilled in the art,the securing means may be reversible, such that plug portions may beseparated, as shown in FIGS. 6B-6C, to reposition the suture ends.

FIG. 7 depicts a perspective view of a plug in a partially opened state.Plug portion 110″ includes first and second plug portions 110 a′, 110b′, which have different sizes. Hinge member 115 is offset from thecenter of plug portion 110″. Further, passage portions 118 a′ and 120 a′of plug portion 110 a′ are each less than 180 degrees. By contrast,passage portions 118 b′ and 120 b′ of plug portion 11 Ob′ are eachgreater than 180 degrees.

During use, a first suture end may be positioned in passage portion 118b′, and then a second suture end is placed in passage portion 120 b′.Since these passage portions are each greater than 180, the suture endsmaybe pressed into the passage portions. Using such a method the sutureends remain at least partially in place. With the suture ends in place,plug portion 110″ is transformed to a closed state. In the closed state,passage portions 118 a′, 118 b′ form a first one-way, 360-degree passagethrough which the first suture end may pass. The second passage portions120 a′, 120 b′ form a second one-way, 360-degree passage through whichthe second suture end may pass.

Referring to FIGS. 8A-8C, yet another embodiment of a plug is described.FIG. 8A is a side view of an embodiment of a plug. FIG. 8B is a sideview of the plug depicted in FIG. 8A in a partially open state. FIG. 8Cis a top view plug depicted in FIG. 8A in a fully open state.

Hinge member 115 is located on a lateral surface of plug portion 110″,as opposed to on the distal end of the plug portion, as shown in detail“D”. Like the embodiment of FIGS. 6A-6C, the embodiment of FIGS. 8A-8Cfacilitates coupling of the suture to the plug portion. During use,threading of the suture through passages 118 and 120 of the plug portionis not required.

As will be apparent to one skilled in the art, passage portions 118 aand 120 a may be larger than passage portions 118 b and 120 b,respectively, as described with respect to FIG. 7 hereinabove.

Referring to FIG. 9, an embodiment of a bone anchor is described. Boneanchor member 180 is similar to bone anchor member 20 of FIGS. 2A-2C,except as noted herein below. Cleated members 182 of bone anchor member180 are similar to cleated members 42 of bone anchor member 20, asdescribed hereinabove, and facilitate anchoring of bone anchor member180 within a hole of a bone. Further, guide channels 190 and 192 aresimilar to guide channels 50 and 52 of FIGS. 2A-2C.

Unlike the embodiments described hereinabove, bone anchor member 180includes at least one adhesive delivery channel 188, which is providedwithin main body 181. Adhesive delivery channel 188 may be formed bydrilling a hole into an upper surface of main body 181, such that thehole extends through first passage 184 and second passage 186. As willbe apparent to one skilled in the art, however, channel 188 may beformed using other known techniques.

First and second passages 184 and 186 may include cleated members 74 ofFIG. 2C, thereby permitting one-way movement of suture ends 32 a and 32b through the passages. Alternatively, passages 184 and 186 may includesubstantially smooth inner surfaces that permit movement of suture 30through the passages in either direction.

After bone anchor member 180 is secured in a hole the bone, the positionof tissue relative to the bone may be approximated by individuallytensioning first and second ends 32 a, 32 b of suture 30, as describedextensively above an incorporated herein. When the tissue has thedesired placement, an adhesive may be delivered to adhesive deliverychannel 188. The delivery of an adhesive to channel 188 may befacilitated using a needle-like tube (not shown) disposed within aworking cannula. The needle-like tube has a distal opening that may beplaced in close proximity to, or within, adhesive delivery channel 188to deliver an adhesive thereto.

The adhesive is allowed to flow distally through adhesive deliverychannel 188 and into portions of first and second passages 184 and 186.The adhesive may contact at least a portion of suture 30 positioned incorresponding regions of first and second passages 184 and 186, therebylocking the suture in place. As will be apparent to one skilled in theart, although one adhesive delivery channel 188 is depicted in FIG. 9,multiple adhesive delivery channels may be employed to secure thesuture, irrespective of whether cleated members 74 are employed.Referring to FIG. 1OA, apparatus 200 includes bone anchor member 202 andplug portion 210. Apparatus 200 is similar to apparatus 140 of FIGS.5A-5C, except as noted below.

Bone anchor member 202 includes main body 203 having bore 204 disposedtherein. Main body 203 of bone anchor member 202 includes exteriorcleated members 206, which are configured to be inserted into a hole ofa bone (e.g., see FIG. 1) using a force fit, as described hereinabove.

Plug portion 210 may be substantially cylindrical in shape and includesmain body 213. Main body 213 has smooth exterior surface 216 and taper217. Optionally, taper 217 may be formed at the distal end of main body213.

Suture 30 having first and second ends 32 a, 32 b is coupled to plugportion 210, preferably in a manner described hereinabove with respectto FIGS. 6-8.

The outer diameter of main body 213 may be sized slightly larger than aninner diameter of bore 204. The size of diameter is selected to allowmain body 213 of plug portion 210 to be distally advanced into bore 204when forced. Taper 207 of bone anchor member 202 is facilitatesadvancement of plug portion 210 into bore 204.

In operation, bone anchor member 202 is secured within a hole of a bonewhen the bone anchor member is distally advanced into the hole, asdepicted in FIG. 1OB. Exterior cleated members 206 of bone anchor member202 permit one-way movement of the bone anchor member into the hole.

Plug portion 210 is advanced distally into bore 204 of bone anchormember 202 and secured therein using a force fit, as describedhereinabove. At this time, surrounding regions of the bone may apply acompressive force upon bone anchor member 202, as indicated by thelarger directional arrows in FIG. 1OB. This compressive force upon boneanchor member 202 in turn causes compression upon plug portion 210, asindicated by the smaller directional arrows in FIG. 1OB; therebysecurely retaining the plug portion within bore 204.

In some embodiments, passages 218 and 219 may include cleated members 74as described hereinabove with respect to FIG. 2C. Alternatively,passages 218 and 219 may include substantially smooth interior surfacesthat permit advancement of suture 30 in either direction.

In certain embodiments, the position of the tissue relative to the bonemay be approximated by individually tensioning suture ends 32 a and 32 bprior to insertion of plug portion 210 into bone anchor member 202. Insome embodiments, the tissue position is approximated when passage 219is disposed just above bore 204. Once the desired positioning of thetissue is achieved, plug portion 210 is advanced distally into bore 204,thereby locking the suture. Specifically, the suture will be sandwichedbetween exterior surface 216 of plug portion 210 and inner wall 205 ofbone anchor member 202.

Referring to FIG. 11, apparatus 220 may include a bone anchor member 222and a plug portion 230. Apparatus 220 is similar to apparatus 200 ofFIGS. 1OA-1OB, except as noted below.

Bone anchor member 222 includes main body 223 having bore 224 disposedtherein, as depicted in FIG. 11. Further, main body 223 includesexterior cleated members 226, which are configured to be inserted into ahole of a bone (e.g., see FIG. 1) using a force fit, as describedhereinabove. Bone anchor member 222 includes a proximal protrusionhaving inward taper 227. Proximal stop 228 is formed between inwardtaper 227 and inner wall 225 of bone anchor member 222.

Plug portion 230 includes main body 233 having proximal region 235,central region 234 and tapered distal region 237. Tapered distal region237 is sized to pass through taper 227 of bone anchor member 222 when adistally directed force is applied to plug portion 230. When furtherforce is applied, central region 234 of plug portion 230 is advancedinto bore 224 via taper 227. When further force is applied to plugportion 230, proximal region 235 is advanced past taper 227. Onceproximal region 235 is fully inserted into bore 224, proximal stop 228is configured to abut proximal edge 236 of plug portion 230, therebysecuring the plug portion within bone anchor member 222.

As will be apparent to one skilled in the art, apparatus 220 may furtherinclude any of the other features described above with respect to theembodiments of FIGS. 2-10. For example, passages 238 and 239 may includecleated members 74 of FIG. 2C, or alternatively may includesubstantially smooth interior surfaces. Further, the operation ofapparatus 220 preferably is substantially similar to the methodsdescribed hereinabove with respect to the embodiments of FIGS. 2-10.

In some embodiments, a bone anchor may be positioned in bone througholeH_(T), which has two openings to the surface of the bone. Referring toFIG. 12, bone anchor 240 is similar to bone anchor member 20 of FIGS.1-2, but is configured for use in applications where through hole H_(T)is employed.

Bone anchor 240 includes main body 242 having proximal and distal ends.Flange 245 disposed at the proximal end and taper 246 formed at thedistal end of main body 242. Main body 242 includes exterior surface 243disposed between flange 245 and taper 246.

Bone anchor 240 includes first and second passages 250 and 252, eachhaving a plurality of cleated members 254. Each of the cleated membersincludes angled sections 255 and substantially orthogonal sections 256,which are disposed adjacent one another thereby forming a cleated shape,as described hereinabove with respect to cleated members 74 of FIG. 2C.

During use, a loop of suture 30 may be coupled through tissue T first,with free ends 32 a and 32 b extending from the tissue. Free end 32 athen is threaded through first passage 250 in a proximal direction. Freeend 32 b is threaded through second passage 252, also in a proximaldirection. The suture may be threaded through passages 250, 252 andtissue T by arthroscopically operating on one or both sides of bone B.

As will be apparent to one skilled in the art, suture 30 may be coupledbetween tissue T and bone anchor 240 using other arthroscopic threadingtechniques, so long as the suture ultimately is situated in a mannerdepicted in FIG. 12.

Once the suture is threaded as shown in FIG. 12, first and second sutureends 32 a and 32 b may be proximally retracted, one at a time, toapproximate the position of tissue T with respect to bone B. As thesuture ends are tensioned, flange 245, which has an outer diameterlarger than the diameter of through hole HT, abuts bone B. The systembecomes tensioned because flange 245 and tissue T are drawn against thebone from opposing directions.

In accordance with one aspect of the present invention, cleated passages250 and 252 are configured to permit one-way movement of first andsecond suture ends 32 a and 32 b, respectively. For example, when firstend 32 a is pulled in a proximal direction, angled sections 255 permitmovement of the suture end in the proximal direction. However, sutureend 32 a is inhibited from distally advancing within passage 250. Theuse of two separate passages allows each end of the suture to beseparately tensioned, which is often desirable when tissue T is tornirregularly.

As will be apparent to one skilled in the art, the methods described inFIG. 12 may be accomplished using a separate bone anchor member and plugportion. For example, the principles of the embodiments in FIGS. 4-5 andFIGS. 10-11, in which separate bone anchor and plug portions areemployed, may be implemented in lieu of one-piece bone anchor 240.

Further, the suture securing methods described in FIG. 12 may beaccomplished using substantially smooth passages 250 and 252. Wheresubstantially smooth passages are employed, an interference fit or anadhesive may be employed in lieu of the cleated passages to facilitatesecuring of the suture. The interference fit or adhesive may be used,for example, as described hereinabove with respect to the embodiments ofFIGS. 4-5 and FIGS. 10-11.

FIG. 13A is a cross-sectional view of an embodiment of an apparatus thatincludes a bone anchor member and a plug portion. As shown in FIG. 13A,apparatus 270 includes bone anchor member 272 and plug portion 280. Boneanchor member 272 includes main body 273 having bore 274 disposedtherein. Main body 273 includes exterior cleated members 276, which areconfigured to be inserted into a hole of a bone (e.g., see FIG. 1) usinga force fit, as described hereinabove. Bone anchor member 272 includes aproximal protrusion having inward taper 277. Proximal stop 278 is formedbetween inward taper 277 and an inner wall of bone anchor member 272.

Bone anchor member 272 includes first and second spring elements 292 aand 292 b, which are disposed at a distal region of bore 274. First andsecond spring members 292 a and 292 b may be integrally formed with boneanchor body 273, or may be separate elements coupled to body 273. Firstand second spring elements 292 a and 292 b may be deformed toaccommodate plug portion 280 within bore 274, and also to enable lockingand unlocking of a suture (not shown in FIGS. 13A-13C) used inconjunction with apparatus 270. As will be apparent to one skilled inthe art, one or more spring elements may be employed.

First and second passages 298 and 299 extend laterally through main body273 of bone anchor member 272. First and second passages 298 and 299 areconfigured to selectively align with first and second passages 288 and289 of plug portion 280, for the purposes described hereinafter.

Plug portion 280 of apparatus 270 includes main body 283 having proximaland distal ends. The proximal end includes flange 284. Taper 286 isdisposed between flange 284 and main body 283. Distal taper 287 isdisposed at the distal end of plug portion 280.

Plug portion 280 includes first and second passages 288 and 289, whichextend laterally through main body 283. In some embodiments, first andsecond passages 288 and 289 include substantially smooth interiorsurfaces.

FIG. 13B illustrates use of apparatus 270. First, plug portion 280 isinserted into bore 274 of bone anchor member 272, using insertion tool294. When an appropriate force is applied to plug portion 280, tapereddistal end 287 passes through taper 277 of bone anchor member 272. Whenfurther force is applied, a central region of plug portion 280 isadvanced into bore 274 via taper 277. When further force is applied toplug portion 280, the proximal region having taper 286 and flange 284 isthen advanced past taper 277.

When plug portion 280 is fully inserted into bore 274, first and secondspring elements 292 a and 292 b are inclined to urge plug portion 280 ina proximal direction, to allow flange 284 to abut proximal stop 278 (seeFIG. 13C). However, when a sufficient distally directed force is appliedto plug portion 280, (e.g., using insertion tool 294) first and secondspring elements may be deformed distally (see FIG. 13B).

Insertion tool 294 may be a rod or other substantially rigid memberconfigured to transfer a distally directed force from a physician toplug portion 290. In some embodiments, insertion tool 294 is engagesmating slot 295, as shown in FIG. 13B.

The provision of distally directed force acting on plug portion 280causes first and second passages 288 and 289 to become substantiallyaligned with first and second passages 298 and 299 of bone anchor member27, respectively, as shown in FIG. 13B. At this time, a suture may bethreaded through aligned first passages 288 and 298. The suture may bethreaded through a tissue, as described hereinabove, and then threadedback through aligned second passages 289 and 299. First suture end 32 aextends through first passages 288 and 298, while second suture end 32 bextends through second passages 289 and 299.

Once the suture is coupled to apparatus 270, apparatus 270 is insertedinto a hole of a bone under arthroscopic guidance. Cleated members 276secure apparatus 270 within the hole, as described hereinabove. At thistime, first and second suture ends 32 a and 32 b will extend outside ofthe arthroscopic field of vision.

First and second suture ends 32 a and 32 b may be selectively tensionedto approximate the positioning of the tissue with respect to the bonewhen first and second passages 288 and 289 are aligned with first andsecond passages 298 and 299, respectively. During tensioning of thesuture ends, insertion tool 294 urges plug portion distally to cause thepassages to align, as shown in FIG. 13B.

When a desired positioning of the tissue is achieved, the force appliedto plug portion 280 is removed (e.g., by proximally retracting insertiontool 294, as shown in FIG. 13C). At this time, first and second springelements 292 a and 292 b are inclined to bias proximally, thereby urgingflange 284 of plug portion 280 against proximal stop 278 of bone anchormember 272. This movement of plug portion 280 with respect to boneanchor member 272 causes a misalignment between first passage 288 ofplug portion 280 and first passage 298 of bone anchor member 272. Also,a misalignment occurs between second passages 289 and 299. Accordingly,the misalignments cause first suture end 32 a to become pinched betweenfirst passages 288 and 298, while second suture end 32 b is pinchedbetween second passages 289 and 299. These misalignments lock the suturein place.

If it becomes necessary to adjust the positioning of the tissue withrespect to a bone during use, then insertion tool 294 may be insertedinto mating slot 295, as shown in FIG. 13B, to urge plug portion 280distally. As described hereinabove, when first and second passages ofplug portion 280 and bone anchor member 272 are aligned (see FIG. 13B),suture ends 32 a and 32 b may be manipulated to adjust the positioningof the tissue.

FIG. 14 is a perspective cross-sectional view of an embodiment of anapparatus that includes a bone anchor member and a plug portion. Theapparatus is similar to the apparatus described in FIG. 13, except asdescribed. Bone anchor member 272′ includes spring element 292′ disposedat a distal end of main body 273. Spring element 292′ includes adistally concave configuration having a central region 293.

Bone anchor member 272′ is used in conjunction with plug portion 280 ina manner similar to that described hereinabove with respect to FIGS.13A-13C. Specifically, after plug portion 280 is inserted into bore 274,the provision of a further distally-directed force acting on plugportion 280 causes central region 293 of spring element 292′ to bedeformed in a distal direction. When the central region of springelement 292′ is deformed distally, first and second passages 288 and 289of plug portion 280 are substantially aligned with first and secondpassages 298 and 299 of bone anchor member 272′, respectively. In thisstate, first suture end 32 a may move substantially unimpeded throughaligned first passages 288 and 298, while second suture end 32 b maymove through aligned second passages 289 and 299, respectively, asdescribed hereinabove with respect to FIG. 13B.

When a desired positioning of tissue is achieved, the force imposed uponplug portion 280 is removed (e.g., by proximally retracting insertiontool 294, as described in FIG. 13C) and central region 293 of springelements 292′ returns in a proximal direction to its preferredorientation. This causes flange 284 of plug portion 280 to be urgedagainst proximal stop 278 of bone anchor member 272′. As describedhereinabove, the movement of plug portion 280 with respect to boneanchor member 272′ causes a misalignment between first passages 288 and298, and also a misalignment between second passages 289 and 299. Thesemisalignments pinch suture ends 32 a and 32 b to lock the suture inplace.

Referring to FIG. 15, an embodiment of an apparatus that includes a boneanchor member and a plug portion is described. FIG. 15A is top view oftop view of an embodiment of an apparatus that includes a bone anchorand a plug portion. FIG. 15 B is a cross-sectional view of the boneanchor depicted in FIG. 15 A along line 15C-15C. FIG. 15C is top view ofthe bone anchor depicted in FIG. 15A in a locked state.

Apparatus 300 includes bone anchor member 302 and plug portion 310. Boneanchor member 302 is similar to the bone anchor members describedhereinabove and includes main body 303 having plurality of cleatedmembers 306, which are configured to anchor plug portion 302 within ahole of a bone (e.g., see FIG. 1). Bone anchor member 302 includescentral bore 304, which is configured to receive plug portion 310.

Plug portion 310 of apparatus 300 includes main body 311 having distalregion 318 and central bore 312, as shown in FIG. 15B. Main body 311 hasan outer diameter that is slightly smaller than an inner diameter ofbore 304. Accordingly, plug portion 310 is configured forcircumferential rotation within bore 304 of bone anchor member 302.

Bone anchor member 302 includes first and second semi-circular channels305 a and 305 b, which are formed at diametrically opposing surfaces ofmain body 303, as shown in FIGS. 15A and 15B. Further, plug portion 310includes first and second semi-circular channels 315 a and 315 b, whichare formed at diametrically opposing surfaces on main body 311, as shownin FIGS. 15A and 15B.

Apparatus 300 also includes actuation knob 321, which is disposed on anouter surface of plug portion 310, as shown in FIG. 15A. Actuation knob321 is configured to be disposed within first recess 322 of bone anchormember 302 in an unlocked state, and disposed within second recess 323in a locked state.

When actuation knob 321 is disposed within first recess 322, first andsecond semi-circular channels 305 a and 305 b of bone anchor member 302are aligned with first and second semi-circular channels 315 a and 315 bof plug portion 310, respectively, thereby forming first and secondcircular channels, as, shown in FIGS. 15A and 15B.

When actuation knob 321 is disposed within second recess 323, first andsecond semi-circular channels 305 a and 305 b of bone anchor member 302are not aligned with corresponding channels 315 a and 315 b of plugportion 310, as shown in FIG. 15C.

During use, suture 30 is coupled to apparatus 300 in a manner shown inFIG. 16. Specifically, first suture end 32 a extends through centralbore 312 of plug portion 310. First suture end 32 a passes throughaperture 327 in plug portion 310 (see FIG. 15B) and transitions intoloop portion 34 a. Loop portion 34 a is threaded through the firstcircular channel formed by semi-circular channels 305 a and 315 a.

Loop portion 34 a then is threaded through a tissue and transitions intoloop portion 34 b. Loop portion 34 b is threaded through the secondcircular channel formed by semi-circular channels 305 b and 315 b. Loopportion 34 b passes through a second aperture 327 and transitions intosecond suture end 32 b. Second suture end 32 b extends through centralbore 312 of plug portion 310.

During use, first and second suture ends 32 a and 32 b may beselectively tensioned when actuation knob 322 is disposed within firstrecess 322, as shown in FIGS. 15A-15B. This is because first and secondsemi-circular channels 305 a and 305 b of bone anchor member 302 arealigned with first and second semi-circular channels 315 a and 315 b ofplug portion 310, respectively, to form the first and second circularchannels through which the suture can freely pass.

It should be noted that, as first and second ends 32 a and 32 b areindividually tensioned, rounded edges 328 of plug portion 310 (see FIG.15B) serve to reduce the shear stresses imposed upon the suture ends asthey pass through apertures 327.

To lock the suture in place, plug portion 310 is rotated with respect tobone anchor member 302 to cause actuation knob 321 to be advanced intosecond recess 323. The rotation of plug portion 310 may be achieved byinserting an actuation tool such as a hexagonal key (not shown) intomating slot 325. Once knob 321 is secured within second recess 323, asshown in FIG. 15C, the suture will be locked in place because themisaligned semi-circular channels pinch the first and second ends of thesuture.

The positioning of tissue may be optimized (e.g., tweaked) with respectto bone after the suture has been locked, the actuation tool may beinserted into mating slot 325 and force applied to cause knob 322 torotate in an opposing direction into first recess 322. As describedabove, this forms two fully circular channels through which the suturemay be advanced or retracted to facilitate positioning of the tissuewith respect to the bone.

FIGS. 17A and 17B depict cross-sectional views of embodiments of a boneanchor in unlocked and locked states, respectively. Referring to FIG. 17A, bone anchor member 340 includes main body 343 having proximal anddistal regions. Bone anchor member 340 includes a plurality of cleatedmembers 346, and opposing guide channels 348 and 349. In someembodiments, guide channels 348 and 349 are similar to guide channels 50and 52 of FIG. 2C.

Bone anchor member 340 includes at least one passage 352 and flexiblemember 350. Passage 352 extends laterally through main body 343.Flexible member 350 is disposed proximal to passage 352. Flexible member350 has a relaxed configuration in which it assumes a convex shape(e.g., bowed away from passage 352). In the relaxed configuration, shownin FIG. 17 A, there is sufficient clearance between flexible member 350and passage 352 to permit suture 30 to move substantially unimpededthrough the passage.

In use, before bone anchor member 340 is inserted into a hole of a bone,first suture end 32 a is passed through passage 352. The first sutureend then becomes loop portion 34 a, which is threaded through thetissue, as described hereinabove. Loop portion 34 a extends through thetissue to become loop portion 34 b. Loop portion 34 b passes backthrough passage 352 and becomes second suture end 32 b. First and secondsuture ends 32 a and 32 b extend outside of the arthroscopic site andmay be individually tensioned during use.

After suture 30 is coupled to apparatus 340 and the tissue, bone anchormember 340 is advanced distally into a hole of a bone (e.g., see FIG.I), whereby cleated members 346 serve to anchor the device in the hole.As described above, first and second suture ends 32 a and 32 b may beindividually tensioned to approximate the positioning of the tissue withrespect to the bone. During this time, no external forces are applied toflexible member 350, thereby permitting movement of the suture withinpassage 352.

Once a desired tissue positioning is achieved, the suture may be lockedin place by apply a distally directed force upon flexible member 350, asdepicted in FIG. 17B. Flexible member 350 preferably assumes a concaveshape in which distal knob 354 is urged towards corresponding pocket 355in bone anchor member 342. The distally directed force locks the suturein place by pinching the suture and inhibiting its movement withinpassage 352.

As will be apparent to one skilled in the art, any number of mechanismsmay be employed to apply a distally directed force upon flexible member350, and further, to lock the flexible member in the concave positiondepicted in FIG. 17B. For example, a plug may be inserted into bore 358,and then wedged against flexible member 350 to hold the flexible memberin place. Alternatively, bone anchor member 340 may include taper 277and proximal stop 278 (see FIG. 17 A) to allow the plug to remain inplace within bore 358. In either case, the plug serves to apply acompressive force to hold the suture in the locked state.

Alternatively, the flexible member may be “bi-stable,” such that theflexible member has only two stable states. In the first state, theflexible member is positioned as shown in FIG. 17 A. When a sufficientdistally directed force is applied, the flexible member is configured to“snap” from the first state into a second state, as shown in FIG. 17B.There are no stable positions between the first and second state.Accordingly, the flexible member is either provided in a locked orunlocked state. Means for applying a proximally-directed force to theflexible member may be used to cause the flexible member to snap fromthe second state, shown in FIG. 17B, to the first state, shown in FIG.17 A, thereby unlocking the device.

In some embodiments, a threaded member may be used to hold the suture ina locked state. As shown in FIGS. 18A-18B, threaded cap 360 has exteriorthread 361, which is adapted to engage grooved interior section 371 ofbore 358′. In certain embodiments, threaded cap 360 includes a proximalregion having mating slot 365 and a distal region having distalprotrusion 362.

In an unlocked state, threaded cap 360 is situated proximally withinbore 358′, as shown in FIG. 18A. To lock the suture in place, lockingtool 375 may be inserted into mating slot 365 and then rotated clockwiseto advance threaded cap in a distal direction (e.g., in a manner similarto tightening a screw). This causes a distal region of threaded cap 360,and distal protrusion 362, to urge flexible member 350 distally, therebyimpinging upon a suture length disposed through passage 352. This locksthe suture in place.

If re-adjustment of the suture, then locking tool 375 may be rotatedcounterclockwise within mating slot 365 to proximally retract thethreaded cap. This will remove the forces imposed upon the suture, asdepicted in FIG. 18A.

In some embodiments, flexible member 350 is omitted entirely. In thiscase, threaded cap 360 may directly pinch the suture in passage 352 tolock the suture in place.

Referring now to FIGS. 19A-19B, an alternative embodiment of the boneanchor of FIGS. 17A-17B is described. Operation of bone anchor member340″ is substantially the same as that of bone anchor 340, with the mainexception that locking member 380 is provided in lieu of flexible member350.

Locking member 380 includes cylindrical body 381, which is configured tobe confined within recess 391 of main body 343″, as shown in FIG. 19A.Locking member 380 includes distal protrusion 382, which is configuredto extend at least partially through aperture 390 of main body 343″.

First and second support members 383 a and 383 b are disposed beneathcylindrical body 381, and may be formed integrally with locking member380. As shown in FIG. 19A, the first and second support members 383 aand 383 b rest on support ledge 395 of main body 343″, thereby elevatinglocking member 380 within recess 391.

During use, suture 30 is secured to a tissue and disposed throughpassage 352″, as described hereinabove with respect to FIGS. 17A-17B.Bone anchor member 340″ then is advanced distally into a hole of a bone(e.g., see FIG. 1), such that cleated members 346 anchor the device inthe hole.

When locking member 380 is elevated within recess 391, distal protrusion382 may not substantially extend into passage 352″, thereby permittingmovement of the suture within passage 352″. At this time, first andsecond suture ends 32 a and 32 b may be individually tensioned toapproximate the positioning of the tissue with respect to the bone.

Once a desired positioning is achieved, the suture may be locked inplace by any number of techniques that cause first and second supportmembers 383 a and 383 b to be lowered or eliminated, thereby loweringcylindrical body 381 within recess 391 and urging distal protrusion 382towards corresponding pocket 355″, as depicted in FIG. 19B. The distallydirected force applied by distal protrusion 382 secures the suture inplace.

In certain embodiments, first and second support members 383 a and 383 bmay be fused with support ledge 395 of main body 343″. In someembodiments, ultrasonic energy is delivered to a proximal surface oflocking member 380, via bore 358″, using techniques that are known inthe art. The provision of ultrasonic energy causes first and secondsupport members 383 a and 383 b to fuse with support ledge 395, therebylowering locking device 380 and locking the suture disposed withinpassage 352″ in place.

In the embodiments of FIGS. 17-19, while only one passage 352 isdepicted, it will be apparent to one skilled in the art that a secondpassage may be provided, (e.g., disposed adjacent to the first passage).If two adjacent passages 352 are provided, then the suture can bethreaded through the first passage, through the tissue, and threadedback through the second passage.

Further, it will be apparent to one skilled in the art that an adhesive,for example, cyanoacrylate, epoxy, bone cement and so forth, may beemployed in conjunction with any of the embodiments described in FIGS.17-19. Such an adhesive may be used in conjunction with apparatusincluding, but not limited to, flexible member 350, threaded cap 360,locking member 380, and any associated components.

FIGS. 20A and 20B are, respectively, a top-sectional view and a sideview of embodiments of a locked state of an apparatus that includes abone anchor and a plug portion. FIGS. 21A and 21B are, respectively, atop-sectional view and a side view depicted in FIGS. 20A-20B in a lockedstate. Apparatus 400 (see FIG. 20A) includes bone anchor member 402 andplug portion 410.

Bone anchor member 402 includes main body 403 having cleated members406, which are configured to secure bone anchor member 402 in a hole ofa bone, as described hereinabove. Bone anchor member 402 also includesfirst and second passages 408 and 412, which extend laterally throughmain body 403.

Bone anchor member 402 further includes guide channels 409 a, 409 b, 413a and 413 b, which are disposed in exterior surfaces of main body 403.The guide channels preferably are similar to guide channels 50 and 52 ofFIGS. 2A-2C, except that four guide channels are employed in the presentembodiment.

In use, first suture end 32 a passes through guide channel 409 a,through passage 408 and through guide channel 409 b. The first sutureend then transitions into loop 34, which is threaded through a tissue.Loop 34 of suture 30 then transitions into second suture end 32 b.Second suture end 32 b passes through guide channel 413 b, throughpassage 412, and through guide channel 413 a. Accordingly, the suture iscoupled between the tissue and apparatus 400.

Plug portion 410 having main body 411 is configured to be disposedwithin a central bore of bone anchor member 402. Plug portion 410includes actuation knob 422, which is configured to be disposed in firstrecess 423 of bone anchor member 402 in an unlocked state, and disposedwithin second recess 424 in a locked state.

In the unlocked state, (e.g., when knob 422 is disposed within firstrecess 423) plug portion 410 is oriented such that main body 411 doesnot substantially overlap with first and second passages 408 and 412 ofbone anchor member 410.

In some embodiments, first and second ends 32 a and 32 b of suture 30are selectively tensioned when knob 422 is disposed within first recess423. This is because first and second passages 408 and 412 provide asubstantially unimpeded circular channel within which the suture canpass.

To lock the suture in place, plug portion 410 is rotated to cause knob422 to be advanced into second recess 424. The rotation of plug portion410 with respect to bone anchor member 402 may be achieved by insertingan actuation tool (e.g., a rectangular key) into mating slot 427. Onceknob 422 is secured within second recess 424, the suture is locked inplace because main body 411 of plug portion 410 impinges upon passages408 and 412.

To adjust (e.g., tweak) the positioning of the tissue with respect tothe bone after the suture is in the locked state, the actuation tool maybe inserted into mating slot 427 to cause knob 422 to rotate back intofirst recess 423 (see FIGS. 20A-20B). This removes the compressiveforces imposed upon the suture, to allow the first and second ends ofthe suture to be individually tensioned, thus facilitatingre-positioning of the tissue.

FIGS. 22A and 22B are cross-sectional views of an embodiment of anapparatus that includes a bone anchor member and a plug portion.

Referring to FIG. 22A apparatus 440 includes bone anchor member 442 andplug portion 450. Bone anchor member 442 includes main body 443 havingcleated members 446, which are configured to secure bone anchor member442 in a hole of a bone (e.g., see FIG. 1). Further, bone anchor member442 includes central bore 444 and circumferential protrusion 449, whichis disposed near a distal end of bore 444.

Plug portion 450 has main body 451 having proximal and distal regions.The proximal region includes first and second guide channels 456 and457, which are recessed in opposing lateral surfaces of main body 451.The distal region of main body 451 includes circumferential recess 453and distal taper 454. Plug portion 410 also has a central region havingpassage 448 disposed laterally therethrough.

Before plug portion 450 is inserted into bore 444, first suture end 32 ais passed through passage 448. The first suture end then becomes loopportion 34 a, which is threaded through a tissue. Loop portion 34 aextends through the tissue to become loop portion 34 b. Loop portion 34b passes back through passage 448 and becomes second suture end 32 b.First and second suture ends 32 a and 32 b may be manipulated duringuse.

Alternatively, as described hereinabove, a central region of suture 30may be threaded through the tissue, and the free ends of the suture thenmay be passed through passage 448 in a proximal direction to achieve thedepicted position of the suture.

In some embodiments, bone anchor member 442 is inserted into a hole ofthe bone before plug portion 450 is inserted into bore 444. Once boneanchor member 442 is securely disposed within the hole, plug portion 450is positioned slightly above bone anchor member 442, so that passage 448is proximal to bore 444. At this time, first and second suture ends 32 aand 32 b may be individually tensioned to approximate the positioning ofthe tissue with respect to the bone (e.g., see FIG. 1).

Once the desired positioning is achieved, plug portion 450 may beadvanced distally into bore 444 of bone anchor member 442. An insertiontool, such as insertion tool 294 of FIGS. 13A-13C, may be inserted intomating slot 458 to advance plug portion 450 distally. The provision of asufficient distally directed force urges taper 454 over circumferentialprotrusion 449, thereby locking the plug portion within the bone anchormember, as shown in FIG. 22B.

At this time, first and second suture ends 32 a and 32 b are compressedwithin guide channel 456, while suture loop portions 34 a and 34 b arecompressed within guide channel 457. Guide channels 456 and 457 may besized to ensure that the suture is completely locked in place when plugportion 450 is inserted into bore 444 (see FIG. 22A). Alternatively,guide channels 456 and 457 may be sized to permit incrementaladjustments of the suture, such that applying a sufficient tension tofree ends 32 a and 32 b will overcome the frictional forces between thesuture, plug portion 450 and bone anchor member 442.

Referring to FIGS. 23A-23C, an embodiment of the 450 of FIGS. 22A-22B isdescribed. FIG. 23A is a cross-sectional view of an embodiment of theplug depicted in FIGS. 22A and 22B. FIG. 23B is a perspective side viewof the plug depicted in FIG. 23A. FIG. 23C is a bottom view of the plugdepicted in FIG. 23A.

In FIG. 23A, plug portion 450′ includes distal passage 466, in lieu ofpassage 448 of FIGS. 22A-22B. Distal passage 466 is formed as a slotrecessed in the distal end of main body 451. Distal passage 466 maycommunicate with opposing guide channels 456 and 457.

The operation of a bone anchor system using plug portion 450′ issubstantially similar to the steps described in FIGS. 22A-22B, with theexception that first and second suture ends 32 a and 32 b are disposedwithin distal passage 466. Specifically, during use, suture ends 32 a,32 b can be looped around the distal end of plug portion 450′, and neednot be inserted by threading through central passage 448. Once thesuture ends are looped around the distal end of plug portion 450′ andconfined within passage 466, then the suture may be held in place whileinserting plug portion 450′ into bone anchor member 442. Once the plugportion is locked into place via circumferential protrusion 449 (e.g.,as described in FIG. 22B), then the suture is compressed between plugportion 450′ and bone anchor member 442.

Referring to FIG. 24A, an apparatus includes alternative bone anchormember 442″ and alternative plug portion 450″. Bone anchor member 442″and alternative plug portion 450″ are similar to bone anchor member 442and plug portion 450 of FIGS. 22A-22B, except as noted below.

Plug portion 450″ includes main body 451′ having first suture clearancechannel 456′ formed in a first lateral surface of the body, and secondsuture clearance channel 457′ formed in an opposing lateral surface ofthe body. Plug portion 450″ also includes clearance recess 455 on adistal region of main body 451′, along with suture channel 466′.

Main body 451′ includes a plurality of cleated members 459 a, which areformed adjacent to suture channel 466′. Also, bone anchor portion 442″includes a plurality of cleated members 459 b formed in bore 444.Cleated members 459 b are configured to oppose cleated members 459 awhen plug portion 450″ is disposed in bore 444 of bone anchor member442″, as shown in FIG. 24B.

During use, suture length 30 a is coupled to bone anchor member 442″ byfirst forming loop 470 between regions 35 a and 35 b of the suture. Acentral portion of suture 30 a then is looped around suture channel 466′of plug portion 450″. At this time, proximal suture ends 33 a and 33 bare proximate clearance channel 456′, while suture regions 35 a and 35 bare in the vicinity of clearance channel 457′. Plug portion 450″ then islowered into bore 444 of bone anchor member 442″, as depicted in FIG.24B.

When an appropriate force is applied, distal taper 454 of plug portion450″ passes over protrusion 449 of bone anchor member 442″. At thistime, protrusion 449 is confined within recess 453, as shown in FIG.24B, to substantially inhibit movement of plug portion 450″ with respectto bone anchor member 442″. Proximal suture ends 33 a and 33 b aredisposed within clearance channel 456′, while suture regions 35 a and 35b are disposed within clearance channel 457′.

In certain embodiments, suture loop 470 may be coupled directly to atissue, as generally set forth hereinabove. Tensioning of suture ends 33a and 33 b may directly affect positioning of the tissue. Further, asset forth above, cleated members 459 a and 459 b may form a one-waychannel that facilitates tensioning of the suture ends, and locks thesuture ends in place. In some embodiments, a second suture length may beemployed to anchor a tissue to a bone. FIGS. 25A-25B are illustrationsof the bone anchor depicted in FIGS. 24A and 24B employing two sutures.

In FIG. 25A, second suture length 30 b has loop 471, which is coupleddirectly to tissue T. Loop 471 is formed between suture portions 34 aand 34 b. Proximal to suture portions 34 a and 34 b, second suture 30 bincludes proximal ends 32 a and 32 b, which are configured to bemanipulated during use.

Second suture 30 b is coupled to first suture 30 a by pulling proximalends 32 a and 32 b through loop 470. At this time, four proximal sutureends will extend proximally from an access cannula (not shown).Specifically, proximal ends 32 a and 32 b of second suture 30 b, alongwith proximal ends 33 a and 33 b of first suture 30 a, all extend fromthe access cannula. Each of the four suture ends may be individuallytensioned during use.

As each of the four suture ends 32 a, 32 b, 33 a and 33 b areselectively tensioned, loop 470 and suture regions 35 a and 35 b areurged towards clearance channel 457′, as shown in FIG. 25B. When loop470 is drawn towards clearance channel 457′, second suture 30 b also isdrawn towards the clearance channel (i.e., because proximal ends 32 aand 32 b of the second suture have been previously pulled through loop470).

At this time, the various suture regions that are drawn towardsclearance channel 457′ become inserted within the clearance channel toeffectively lock the sutures in place. In effect, as tension is appliedto the four suture ends 32 a, 32 b, 33 a and 33 b, tissue T isapproximated to bone, and ultimately, the sutures are locked in place.

The use of the described method may save considerable time and effortduring a surgical procedure. For example, bone anchor member 442″, plugportion 450″ and first suture 30 a (including loop 470) may be providedin an already assembled state, as shown in FIG. 24B. These componentsneed not be assembled during the surgical procedure.

At an appropriate time, second suture 30 b is coupled to tissue T vialoop 471. Using this method, it is not necessary to thread proximalsuture ends 32 a and 32 b through plug portion 450″ or bone anchormember 442″ after suture 30 b is coupled to tissue T. Rather, sutureends 32 a and 32 b are pulled through loop 470 of first suture 30 a. Inshort, first suture 30 a is coupled to tissue T, and then proximal ends32 a and 32 b are guided through previously provided loop 470, therebysaving operating time and effort.

Referring to FIGS. 26A-26D, an apparatus that includes a bone anchor isdescribed. FIG. 26A depicts an embodiment of bone anchor 500. FIG. 26Bis a cross-sectional view depicting a suture locking mechanism of thebone anchor depicted in FIG. 26B in a locked position. FIG. 26C is across-sectional view depicting the suture locking mechanism depicted inFIG. 26B in an unlocked position. FIG. 26D is an exploded view of thebone anchor of depicted in FIG. 26A.

Bone anchor 500 includes main body 502 and insert 504. Main body 502 hascleats 506, which are used to secure the bone anchor 500 to bone asdiscussed above. Main body 502 may have any other suitable feature tosecure the anchor 500 to bone, such as an expandable portion, withoutdeparting from the scope of the invention.

Insert 504 is positioned in recess 508 in main body 502. The sutureenters apparatus 500 through the proximal end of recess 508 and extendsthrough a space between main body 502 and insert 504. The suture thenpasses hole 510 in insert 504. Hole 510 is, in some embodiments,triangular shaped to accommodate different size suture as shown in FIG.26D.

Insert 504 is movable between the closed position of FIG. 26B and theopen position of FIG. 26C. Recess 508 has beveled surface 512 on eachside facing the hole 510 in the insert 504. The suture is capturedbetween beveled surface 512 and upper end 514 of hole 510 when insert504 is in the closed position of FIG. 26B. Insert 504 may be biasedtoward the closed position by spring portion 516 on insert 504. Springportion 516 is formed by spiral cut 518 in insert 504. Insert 504 alsohas pinned connection 520 with main body 502 near the distal end. Pin522 extends through hole 524 in insert 504 to provide pinned connection520. Although spring portion 516 is formed integral with insert 504 aseparate spring may also be provided similar to other embodimentsdescribed herein.

Insert 504 may be moved to the unlocked position of FIG. 26C by pullingon insert manipulator 524. Manipulator 524 may simply be flexible tether526, which is pulled to move insert 504 to the unlocked position. Whenthe procedure is completed, tether 526 may be cut and removed.Manipulator 524 provides the user with the ability to adjust suturetension as needed. Bone anchor 500 is used in the same or similar manneras the other apparatuses described herein.

Referring to FIGS. 27A-27B, bone anchor 530 is described. FIG. 27A is aperspective view of an embodiment of a bone anchor. FIG. 27B is across-sectional view of the bone anchor depicted in FIG. 27 A. FIG. 27Cis an exploded view of the bone anchor depicted in FIG. 27A.

Bone anchor 530 has main body 532 with cleats 531 used to secure thebone anchor to bone although any other feature may be provided to securebone anchor 530 to bone. The suture is locked with a suture lock 533.Suture lock 533 permits the suture to be advanced in the direction ofarrow 556, but prevents movement in the other direction. The sutureextends around bearing surface 534. Bearing surface 534 may be roller536 although a non-rotating member may also be used. Roller 536 ismounted within hole 538. Suture lock 533 has first locking portion 540and second locking portion 542, but may include any number of lockingportions.

The first and second locking portions 540, 542 are integrally formed asring clip 550. Ring clip 550 seats within annular recess 552 in mainbody 532. Suture locks 540, 542 include suture engaging portion 554extending from ring clip 550. Locks 540, 542 may include an integrallyformed living hinge 556. Living hinge 556 may permit the suture engagingportion 554 to deflect inwardly when suture is pulled in the directionof arrow 556. Suture lock 533 permits the suture to be pulled in thedirection of arrow 556 and prevents the suture from being moved in theopposite direction. Bone anchor 530 is used in the same manner as boneanchors described herein.

Referring to FIGS. 28A-28D, bone anchor 560 is described. FIG. 28A is aperspective view of an embodiment of bone anchor 560. FIGS. 28B and 28Care cross-sectional views illustrating the use of a release element inconjunction with the bone anchor depicted in FIG. 28A. FIG. 28D is anexploded view of the bone anchor depicted in FIG. 28A. Bone anchor 560is used in the same manner or similar manner as other bone anchorsdescribed herein.

Bone anchor 560 includes suture lock 564. Suture lock 564 allows asuture to be pulled in the direction of arrow 566, and prevents movementin the other direction. Suture lock 564 includes cam 568 having pinnedconnection 570 formed by pin 571 rotatable within hole 573 (see FIG.28D). The suture is locked when the suture is trapped between cam 568and inner surface 574 of main body 572.

Bone anchor 560 includes release element 576 for releasing suture lock564. Release element 576 may be part of introducer 578. Introducer 578may be used when advancing bone anchor 560 into bone. Release element576 extends through a channel of introducer 578. Release element 576 andmain body 572 may be configured (e.g., threaded) to allow the releaseelement to be rotated and advanced to a desired position (e.g., asdepicted in FIG. 28B). Release element 576 contacts upper portion of cam568 and pivots the cam (e.g., as depicted in FIG. 28C). Pivoting the campermits manipulation of the suture in one or more desired directions.

Further Improvements

Referring to FIG. 29, an alternate non-limiting embodiment of a boneanchor 600 is shown. FIG. 29A depicts an embodiment of a bone anchorhaving a cam with a suture positioned between the cam and a surface atthe distal end of the bone anchor. FIG. 29B is a cross-sectional view ofthe embodiment depicted in FIG. 29A. FIG. 29C is a frontal view of thebone anchor depicted in FIG. 29A. FIG. 29D is an exploded view of thebone anchor and suture depicted in FIG. 29A.

It will be apparent to practitioners of ordinary skill in the art that,while the non-limiting embodiment of bone anchor 600 depicted in FIG.29A-29D has a substantially flattened profile, such a configuration ismerely meant to be illustrative of the many alternate shapes that thepresently described bone anchors may take. In different embodiments,bone anchor 600 may be configured to have cross sectional shapes and/ordimensions different from that depicted here, without departing from thespirit or scope of the embodiments set forth herein.

Bone anchor 600 may include main body 610 with sides 611. Sides 611 mayform cavity 612. Sides 611 may entirely or at least partially enclosecavity 612. The cavity may extend distally along the entire length ofthe main body, or may optionally extend along only a portion of thelength of the main body. Cavity 612 extends to the proximal end of themain body to form opening 613.

Main body 610 has inner surface 615 positioned at the distal end of endof cavity 612. Inner surface 615 may be formed from the main body at thetime of its manufacture, or may be formed by coupling block 616 to thedistal end of main body 610 (see FIG. 29D).

In some embodiments, opening 613 may be fully surrounded at the proximalend of main body 610. In certain embodiments, side surfaces 640 arecoupled to main body 610 to enclose opening 613. Side surfaces 640 maybe formed from the main body at the time of its manufacture, or may beformed by coupling retainer 645 to the proximal end of main body 610, asdepicted in FIG. 29D.

Referring to FIG. 29A, bone anchor 600 may include cam 650 pivotallypositioned in cavity 612. Cam 650 is pivotally coupled to main body 610using, without limitation, any suitable art-recognized means of forminga rotatable connection. (e.g., a pin). In one non-limiting embodiment,cam 650 may be positioned in cavity 612 such that hole 651 is alignedwith holes 652 on opposite sides 611, as depicted in FIG. 29D. Pin 653may be inserted through the aligned holes to couple cam 650 to main body610. This connection enables cam 650 to rotate (e.g., pivot) about theaxis of pin 653, as shown in FIG. 29B.

In some embodiments, cam 650 may be configured to have an irregularcross sectional shape. FIGS. 29A-D depicts an embodiment where the crosssectional shape of cam 650 is substantially ovoid (e.g., seeparticularly FIG. 29B and FIG. 29D). It will apparent to a practitionerof ordinary skill in the art however, that the configuration of the campresently described embodiment is exemplary only and serves toillustrate one of the many configurations of cams suitable for use withthe subject bone anchors. It will be apparent to ordinary practitionersof the art that cams configured with any cross sectional shape may besubstituted for that described herein without departing from the scopeof the presently described embodiments.

Coupling cam 650 to main body 610 as described above allows the cam tofreely pivot in cavity 612. In an embodiment, cam 650 may pivot in afirst direction (e.g. downward) until outer cam surface 667 comes intocontact with inner surface 615 (e.g., as depicted in FIG. 29B). Aftercontact, further rotation of cam 650 in the first direction is blocked.Cam 650 may, however still pivot in the opposite direction (e.g.upward).

In some embodiments, cam 650 may be configured such that cam surface 667is biased toward inner surface 615. Any suitable art-recognized meansmay be used to bias cam surface 667 toward inner surface 615. Examplesof methods to bias a cam include, but are not limited to, coupling thecam to a spring bias assembly, or by forming at least a portion of camand/or inner surface of the main body from a magnetized material.

Referring to FIG. 29A, one or more coupling members 630 may be disposedon the exterior surface of main body 610. Coupling members may be usedto secure bone anchor 600 to an opening in a bone in which the boneanchor is positioned. Main body 610 may include any other suitablefeature to secure the bone anchor 600 to bone, such as an expandableportion, without departing from the scope of the invention.

In an embodiment, coupling members 630 may extend radially from the mainbody. In an embodiment, coupling members 630 may be configured toreversibly engage a bone surface. Typically, coupling members may beformed, at least in part, of a substantially rigid or deformablematerial. In an embodiment, the coupling members are formed from themain body during the time of its manufacture. In some embodiments,coupling members may be manufactured separately and coupled to theexterior surface of the main body. In some embodiments, the main bodymay be coupled to the coupling members at the in a point of caresetting. The main body may be configured to fit to a variety of couplingmembers, each having unique features suited to particular applications.A choice of coupling members may be provided to the physician at thepoint of care and coupled to the main body. Such a system allows thephysician to choose the coupling member(s) best suited to a particularpatient and application (e.g., size, depth and/or width of the bonehole), without having to interrupt and prolong the procedure underway inorder to choose an alternate bone anchor and prepare it forimplantation. The coupling of a main body to coupling members may be byany suitable means generally known in the art. By way of non-limitingexamples, a main body may be coupled to coupling members using asnap-locks, screws, adhesives, or any other suitable means describedabove or generally known in the art. A non-limiting example is depictedin FIG. 29A. A physician may choose clip 620, which includes one or moreradially extendable coupling members 630. After the choice is made, thebone anchor is readied for use by coupling clip 620 to main body 610. Inan embodiment, a pinned connection may be formed by aligning hole 623with hole 622 and inserting pin 621 through the aligned holes, asdepicted in FIG. 29D. Coupling members 630 extend radially from mainbody 610.

In an embodiment, a bone anchor may be positioned in an opening in abone by first retracting the coupling members. Retraction may beaccomplished using a device (e.g., an inserter) that is capable ofgrasping the coupling members and compressing them toward the main body.When the bone anchor is suitably positioned in the bone opening, theinserter releases coupling members, allowing them to move radiallyoutward and engage the surface of the bone opening. Alternatively, thebone anchor may be inserted into a bone opening without retracting thecoupling members, and allowing the coupling members to grip the surfaceof the opening in which the bone anchor is placed.

Suture 660 may be positioned in bone anchor 600 to allow tensioning oneor both ends of the suture to optimize positioning of the tissuerelative to the bone. Suture 660 includes distal loop portion 665, whichis coupled to the tissue, and suture end portions 662 a, 662 b, whichare coupled to bone anchor 600. During use, suture end portions 662 aand 662 b may be tensioned so that the tissue is drawn toward the boneanchor. Suture end portions 662 a, 662 b may be coupled to bone anchor600 by entering through opening 613.

Suture end portions 662 a, 662 b extend toward the distal end of mainbody 610. To engage cam 650, suture end portions 662 a, 662 b may bewrapped around at least a portion of outer surface of cam surface 650.Optionally, cam 650 may be textured on at least a portion of its outersurface. The texturing may allow the cam surface to frictionally gripthe suture. The sutures may be wrapped around cam 650 such that thesuture contacts at least about 30%, at least about 40%, at least about50%, at least about 60%, or at least about 70% of the outer surface ofcam 650. In an embodiment, suture end portions 662 a, 662 b may bewrapped around cam 650 in a hairpin configuration as shown in FIGS. 29Aand 29B. By wrapping suture end portions 662 a, 662 b around the lowersurface of the cam, the suture ends are positioned in space 666 betweenouter cam surface 667 and inner surface 615. Wrapping the suture aroundthe cam in a hairpin configuration may maximize contact between thesuture length and the outer surface of the cam. Thus, traction betweenthe cam surface and the suture length is enhanced. After being coupledto cam 650, suture end portions 662 and 663 may extend toward theproximal end of main body 610 and exit through opening 613. In anembodiment, side surface 640 may hold suture end portions 662 and 663 inplace at opening 613 (See FIG. 29B), allowing the physician greateraccess to the suture and ease of manipulation of the suture during use.

In an embodiment, a suture puller (not shown) may facilitate threadingof the suture ends through the bone anchor described above and shown inFIGS. 29A-D. The suture puller may be similar in shape and size to thesuture coupled to the tissue. In some embodiments, the suture puller issubstantially S-shaped.

The suture puller may be threaded through the bone anchor in the samemanner as the suture, prior to the positioning of the anchor in a boneopening. The distal end of the suture puller couples to ends of thesuture. During use, a loop of suture may pass through a tissue ofinterest. The end portions of the suture may couple to the distal end ofthe suture puller. Pulling a proximal end of the suture puller passesthe suture puller through the main body of the bone anchor and threads aportion of the suture end through the opening in the main body, aroundthe cam, between the outer cam surface and the inner surface of the mainbody, and out through the opening in the cavity.

When the suture is coupled to tissue and appropriately threaded throughbone anchor 600, the sutured tissue may be drawn toward the bone byindividually, or together, tensioning suture end portions 662 and 663 inthe direction indicated by arrow 690 shown in FIG. 29B. Tensioning thesuture causes cam surface 667 to move (e.g., pivot) away from innersurface 615, allowing movement of suture end portions 662 and 663 in thedirection indicated by arrow 690. It will noted however that, due to theconfiguration of cam surface 667 relative to inner surface 615, afterthe tension applied to suture end portions 662 and 663 is released, camsurface 667 returns to its position adjacent to inner surface 615.Tension applied to suture end portions 662 and 663 in the directionindicated by arrow 695 locks the suture in place by compressing endportions 662 and 663 between cam surface 667 and inner surface 615.Thus, movement of a tissue coupled to a suture is allowed only in adesired direction, while slippage or movement of the tissue back to itsoriginal position is substantially prevented.

FIGS. 30A-D describe bone anchor 700. FIG. 30A depicts an embodiment ofthe bone anchor having a suture locking assembly. FIG. 30B is across-sectional view of the bone anchor depicted in FIG. 30A. FIG. 30Cis a side view of the bone anchor depicted in FIG. 30A. FIG. 30D is anexploded view of the bone anchor depicted in FIG. 30A.

Bone anchor 700 includes insert 710 and main body 715. Insert 710includes one or more (e.g., a plurality) of flange members 711 (see FIG.30D). Flange members 711 may extend proximally from insert 710. Cavity720 is formed between flange members 711. Distal end of cavity 720includes inner surface 719 (see FIG. 30B).

In some embodiments, main body 715 may be configured to couple to insert710. As depicted in FIG. 30B, main body 715 is configured to accept andencircle flange members 711 and cavity 720. Main body 715 may couple toinsert 710 by aligning hole 701 a in main body 715 with holes 701 b inflange members 711 (see FIG. 30D). Pin 705 may then be inserted thoughthe aligned holes. Any alternate configurations of insert 710 and mainbody 715 that allow coupling thereof are possible and their means ofcoupling, without departing from the spirit and scope of the embodimentsprovided herein may be used.

Main body 715 may optionally include a plurality of radial couplingmembers 716. Radial coupling members 716 may secure bone anchor 700 tobone as described herein. Main body 700 may employ any art-recognizedmeans for securing the anchor 700 to bone including, but not limited to,cleats.

Bone anchor 700 may also include locking assembly 740. Locking assembly740 includes a plurality of locking elements 750. In FIG. 30D, lockingelements 750 are depicted as locking rings 750 a and 750 b. Lockingrings 750 a and 750 b include upper bar 751 a and 751 b and lower bar752 a and 752 b, respectively. Locking rings 750 a and 750 b are sizedto allow, when the locking rings are positioned parallel to each other,lower bars 752 a and 752 b to enter cavity 720 as depicted in FIG. 30B.Locking rings 750 a and 750 b may be positioned parallel to each otherwhen lower bars 752 a and 752 b are disposed in cavity 720. In someembodiments, the locking rings are substantially parallel to each other.Lower bars 750 a and 750 b may be individually disposed at variouspositions or at the same position relative to inner surface 719 ofcavity 720. In FIG. 30B, lower bar 752 b is positioned adjacent to or incontact with inner surface 719. In some embodiments, lower bar 752 a ispositioned substantially adjacent to or in direct contact with innersurface 719. In contrast, lower bar 752 a is positioned along thelongitudinal axis of cavity 720, at a distance farther from innersurface 719 than lower bar 752 b. Similarly, upper bar 751 b is closerto the opening of cavity 720 than upper bar 751 a. Suture gap 760 liesbetween upper bars 751 a and 751 b and is sized to accommodate thethickness of a suture. The locking assembly described above may bereferred to in some embodiments as a “two bar locking assembly.”

In one embodiment, one or more of locking elements 750 may be axiallymovable in cavity 720. Moving locking element 750 in an axial directionmay, in some embodiments, allow the locking elements to interact witheach other to either lock or release a suture length positioned in gap760 by compressing the suture length between upper bars 751 a and 751 b.In some embodiments, locking element 750 may be moved axially afterdesired positioning of a sutured tissue (e.g., after fine-tuningplacement of the tissue), in order to reversibly lock the suture inplace. Axial movement of locking elements 750 may be accomplished usingany art-recognized means, including those described in detail above.

Suture 780 is positioned in bone anchor 700 to allow optimal positioningof a tissue relative to the bone by individually tensioning the ends ofthe suture, while substantially inhibiting movement of the suture andtissue coupled thereto in the opposite direction.

In some embodiments, suture 780 is configured to have a distal loopportion 785 and proximal suture end portions 781 a and 781 b. Distalloop portion 785 couples to tissue. Suture end portions 781 a and 781 bmay be treaded through the locking assembly of bone anchor 700, and whentensioned in the direction indicated by arrow 790, draw the tissuetoward the bone anchor. In some embodiments, suture end portions 781 aand 781 b may be threaded through a two bar locking assembly as depictedin FIGS. 30A and 30B. Loop portion 785 is positioned distally to boneanchor 700, at the tissue. Suture end portions 781 a and 781 b maycouple to locking assembly 740 by passing the suture end portionsthrough the opening of ring 750 a and under upper bar 751 b. Suture endportions 781 a and 781 b are wrapped upward around upper bar 751 b,passed though suture gap 760 and wrapped upward around upper bar 751 a.Suture end portions 781 a and 781 b are then available for facilitationof positioning of the sutured tissue (see FIG. 30B).

In certain embodiments, a suture puller may facilitate threading of thesuture ends through the two bar locking assembly as described above. Thesuture puller may be similar in shape and size to the suture coupled tothe tissue, and may be threaded through the bone anchor in the samemanner as the suture, prior to the positioning of the anchor in a boneopening. The distal end of the suture puller couples to suture endportions 781 a and 781 b. During use, a loop of suture passes through atissue. The end portions of the suture are coupled to the distal end ofthe suture puller. Pulling the proximal end of the suture puller in adesired direction (e.g., direction 790) passes the suture puller throughthe locking assembly and threads suture end portions 781 a and 781 bthrough ring 750 a, under and around upper bar 751 b, passed thoughsuture gap 760 and finally wrapped around upper bar 751 a.

When the suture is coupled to tissue and appropriately threaded throughthe locking assembly of the bone anchor, the sutured tissue may be drawntoward the bone by individually or together tensioning suture endportions 781 a and 781 b in the direction indicated by arrow 790 shownin FIG. 30B. Tensioning the suture ends thus allows the threaded sutureto move through the locking assembly in direction 790, thus drawingtissue toward the bone. It will noted however that, due to theconfiguration of the two bar locking assembly relative to the threadedsuture, movement or slippage of the tissue in an opposite direction issubstantially inhibited. Tensioning the suture distally, in thedirection indicated by arrow 795, causes the suture to apply an upwardforce to upper bar 751 b, causing upper bar 751 b and 751 a to interactsuch that the suture length positioned in gap 760 is compressed betweenthe upper bars, thus substantially locking the suture in place.

Turning now to FIG. 31, an alternate view of a bone anchor 800 is shown.FIG. 31A shows bone anchor 800 in which upper bars 851 a 1 b of two barlocking assembly 840 are configured to be substantially straight. FIG.31B shows a cross sectional view of bone anchor 800. FIG. 31 C shows anexploded view of bone anchor 800, including two bar locking assembly 840having locking elements 850 alb with straight upper bars 851 a/b.

The bone anchor embodiments depicted in FIGS. 30 and 31 may be preferredfor applications in which the bone anchor is to be inserted in softbone. For example, radial coupling members 716 and 816 may be preferablewhen bone anchors 700 and 800 are to be inserted into a bone tunnel insoft bone. It will be understood by an ordinary practitioner of the arthowever, that other means of engaging the bone of a bone tunnel may beused in applications in which the bone anchor is to be inserted inharder bone, without departing from the spirit and scope of thepresently described embodiments. It will further be understood that thematerial from which the above-described locking assemblies are made isnot limited to any preferred material. However, in certain embodiments,locking rings may be made from an appropriate biocompatible memorymaterial, such as nitinol.

FIG. 32 shows an alternate embodiment of that depicted in FIG. 31. FIG.32A shows an embodiment of a bone anchor assembly 900 in which radialcoupling members 816 are replaced by one or more cleated members 946.Cleated members 946 may facilitate the insertion of bone anchor assembly900 into a bone tunnel in hard bone, and aid in the engagement thereofwith bone on the surface of the tunnel. FIG. 32B shows a cross sectionalview of bone anchor 900. FIG. 32C shows an exploded view of bone anchor900, including two bar locking assembly 940 having locking elements 950a 1 b with straight upper bars 95 1 alb.

FIGS. 33 and 34 show further alternate embodiments of bone anchorassemblies 1000 and 1100 in which suture 1060 is coupled to bone anchors1000 and 1100, respectively, in a fixed position rather than beingcoupled thereto using a two bar locking assembly. In the non-limitingembodiments depicted in FIGS. 33 and 34, a middle portion of suture 1060is coupled to body 1070 or 1170, and suture ends 1062 a 1 b extenddistally therefrom toward the surgeon.

FIG. 35A-35G show various alternate embodiments of bone anchors suitablefor use with the presently described systems and methods.

Modular Design

Bone anchor 600 described certain embodiments where the main body isconfigured to be used with a variety of different coupling members, eachhaving features suited to particular applications. It will be readilyappreciated by ordinary practitioners of the art however, that thisfeature is not limited to the embodiments of bone anchor 600. Neither isthis feature meant to be limited to the coupling of an internal portionto an external portion. In the contrary, components of the bone anchorassemblies described above are designed with the feature of modularityin mind. The ability to mix-and-match different features of an internalportion of a bone anchor assembly with a wide variety of features ofexternal portions of the bone anchor is intended to be applied, withoutlimitation, to all the embodiments described herein.

Incorporating the feature of modularity into the bone anchor assemblydesign parameters provides the following advantages: (a) maximizedversatility in surgical applications without having to redesign boneanchor suited to such applications; (b) maintaining flexibility of thesurgical procedure at the point-of-care; (c) full interchangeability ofany component with any other component; (d) adjustability of each boneanchor component independent of the choice or position of other boneanchor components being used in a single surgical application; (e)allows the surgeon to tailor the assembly to the individual anatomy ofthe patient even in the face of a revision of the surgical procedurethat might otherwise damage the bone or tissue; and (f) the use of allstyles and sizes of interior and exterior components. The feature ofmodularity allows the physician to dedicate his or her full attentionthe procedure at hand, improving the prognosis and healing of thepatient.

Securing a bone anchor member within a hole of a bone may be employed aspreviously described or using generally known bone securing techniques.For example, cleated members 42 of FIG. 2A, may be used means forsecuring the bone anchors. Other alternative means for securing may beused in conjunction with the apparatus and methods of the presentinvention. As an example, the bone anchor member may employ one or moreradially expandable members that extend into the surrounding bone.

Further, while some of the embodiments of the present invention describeuse of a bone anchor member only, and other embodiments describe use ofa bone anchor member and a plug portion, many of these features may beinterchanged. It will be apparent to one skilled in the art that manyembodiments depicting a bone anchor member only may be performed using abone anchor member and plug portion, and vice versa.

Also, for those embodiments described above having a bone anchor memberand a plug portion, it will be apparent to those skilled in the art thatthe suture ends may be tensioned either before or after the plug portionis inserted into the bore of the bone anchor member.

It will also be apparent to one skilled in the art that the plug portionmay be securely disposed within the bore of the bone anchor member usingvarious means not specifically disclosed herein. For example, after theplug portion is inserted into the bore of the bone anchor member, anadhesive, for example, cyanoacrylate, epoxy, bone cement and so forth,may be delivered to affix the plug portion to the bone anchor member.Alternatively, an exterior surface of the plug portion may be coatedwith a biocompatible adhesive that affixes to the bone anchor memberafter the plug portion is inserted into the bore of the bone anchormember. In some embodiments, heat may be applied to fuse the plugportion to the bone anchor member. It will be apparent to one skilled inthe art that still further means for securing the plug portion to thebone anchor member may be employed.

It should be understood that multiple bone anchor members, or multiplebone anchor members coupled to respective plug portions may be used. Oneor more sutures may be coupled between a desired tissue region and thebone anchor member or plug portion. If multiple sutures and bone anchormembers are employed, enhanced sequential tensioning of the tissue maybe achieved.

Finally, while the above-described embodiments reference use ofapparatus and methods for facilitating attachment of tissue to bone, itwill be apparent to one skilled in the art that such apparatus andmethods may also be used to secure tissue-to-tissue and bone-to-bone.

Bone Anchor Inserter Systems and the Uses Thereof

The presently described embodiments may optionally be provided incombination with an installer system adapted for use in deploying thepresently described bone anchors to the operative site.

A system for deploying a bone anchor to an operative site may include abone anchor installer device. FIG. 36 shows a bone anchor installerdevice 1200 according to a first non-limiting embodiment. Bone anchorinstaller 1200 may include anchor loading tool 1205 having a proximalhandle portion 1210 and an elongated anchor loading portion 1220extending distally therefrom. In an embodiment, a bone anchor installermay further include an anchor holder 1230 coupled to the distal end ofanchor loading portion 1220. Anchor holder 1230 may be configured tohold a bone anchor in place at the distal end of the installer prior tothe deployment thereof in a bole prepared in bone. In an embodiment,anchor holder 1230 may include pin 1235 detachably coupled thereto.During use, a bone anchor loaded to installer 1200 may be deployed bydetaching pin 1235 from anchor holder 1230. Detaching pin 1235 in thisway may allow the uncoupling of anchor housing 1230 from the distal endof installer loading portion 1220, and exposing the bone anchor loadedon the distal end thereof (described below). In an embodiment, a systemfor deploying a bone anchor may optionally include suture puller 1240pre-loaded through the bone anchor in the anchor holder. Suture puller1240 may be pre-loaded to the installer device in such a way as tofacilitate the threading of one or more suture ends through a two barlocking assembly, as described above. Suture puller 1240 may includegrasping portion 1250, which extends proximally from anchor holder andis readily accessible to the surgeon during use. Suture puller 1240 mayfurther include loop portion 1245 at its distal end. Loop portion 1245may be configured to hold suture ends while they are being pulledthrough anchor holder 1230 and loaded to the bone anchor residingtherein as described in greater detail below.

Turing to FIG. 37, anchor holder 1230 is shown in greater detail. In anembodiment, an anchor holder coupled to the distal end of an installermay include a first holder portion 1231 and a second holder portion 1232configured to be reversibly coupled to each other so as to define anchorholder 1230. First and second holder portions 1231 and 1232 may definechannel 1234 along the longitudinal axis of the anchor holder. Channel1234 may be sized to accept bone anchor 700 and the distal end ofloading portion 1220 of anchor loading tool 1205.

In an embodiment, first and second holder portions 1231 and 1232 may becoupled to each other by way of pin 1235 as depicted in FIG. 37A. In analternate embodiment, first and second holder portions 1231 and 1232 maybe held together through slideable ring 1236, when engaged encompassesthe holder portions. Pin 1235 and ring 1236 may be used as a means ofkeeping anchor holder 1230 assembled. Pin 1235 and ring 1236 may be usedeither alone or in combination. First and second holder portions 1231and 1232 may be configured to define canal 1234 when they are coupled,as shown in FIG. 37A. Canal 1234 extends substantially along thelongitudinal axis of anchor holder 1230. The diameter of canal 1234 issized to accept bone anchor 700, or any of the previously disclosedalternate bone anchor embodiments. Though not shown here, the diameterof canal 1243 is also sized to accept the distal end of anchor loadingportion 1220.

As discussed above, first and second holder portions 1231 and 1232 maybe coupled by way of pin 1235. Pin 1235 may reside in a channel definedby bore 1236 (FIG. 37B), which extends through at least a portion of thebody of anchor holder 1230, at an axis substantially perpendicular tothat of canal 1234. To uncouple first and second holder portions 1231and 1232, pin 1235 may be removed from bore 1236. Alternatively,slidable ring 1236 may be moved in such a way (e.g., FIG. 37B) thatfirst and second holder portions 1231 and 1232 are no longer coupledtogether.

FIG. 38A shows an enlarged cross sectional view of the distal end ofbone anchor installer device 1200 according to an embodiment, where aportion of anchor holder 1230 is removed. Bone anchor 700 may be loadedto the distal end of anchor loading portion 1220 and help in place byanchor holder 1230. Optionally, anchor 700 may be tethered to theproximal end of anchor loading tool 1205 by way of tether 1260 locatedin lumen 1221, which may extend along the longitudinal axis of anchorloading portion 1220 and optionally as far as handle portion 1210. In anembodiment, one end of tether 1260 may be coupled to a portion of thebone anchor (e.g., to one of the two rings defining the two bar lockingmechanism) and the other end may extend to the proximal end of theanchor loading tool. In an embodiment, tether 1260 may be accessible tothe surgeon during use. In an embodiment, the tension of tether 1260 maybe varied so as to keep bone anchor 700 loaded on the anchor loadingtool after anchor holder 1230 has been removed.

In an embodiment, a bone anchor installer system may also include suturepuller 1240 pre-loaded through the bone anchor in the anchor holder.Suture puller 1240 may be pre-loaded to the installer device in such away as to facilitate the threading of one or more suture ends through atwo bar locking mechanism of a bone anchor, at the time of itsdeployment. In an embodiment, suture puller 1240 may include graspingportion 1250 at one end. Grasping portion 1250 may be exterior to anchorholder 1230 and be readily accessible to the surgeon during use. Suturepuller 1240 may further include loop portion 1245 at the other end. Loopportion may also be exterior to the anchor holder, such that it isaccessible for coupling to suture ends. In an embodiment, the centralportion of suture passer 1240 may be substantially disposed in anchorholder 1230, and threaded through at least the two bar locking mechanismof a bone anchor in such a way to enable the suture ends to be properlyloaded thereto. As shown in FIG. 38A, a portion of suture puller 1240closer to loop portion 1245 may pass under the lower bar of the lockingassembly, and a portion of suture puller 1240 closer to grasping portion1250 may pass between the two bars of the locking assembly. Optionally,the intervening portion of the suture puller may be looped around pin1235.

FIG. 38 B is a side sectional view of the device shown in FIG. 38A, inwhich the arrangement of bone anchor 700 and anchor loading portion 1220relative to each other and to anchor holder 1230 is shown. In this view,suture puller 1240 is not shown.

FIG. 39 shows bone anchor installer device 1200 prior to deployment.FIG. 39B shows an enlarged view of the distal end of the installer,including suture puller 1240 threaded through bone anchor 700 (not seen)as described above. In an embodiment, anchor holder 1230 may includeslit 1233, through which loop portion 1245 and grasping portion 1250 maypass.

FIG. 40 depicts a procedure for deploying a bone anchor using a boneanchor installer device according to an embodiment. Turning to FIG. 40A,cannula 1260 may be placed in tissue 1275 so as to make accessible thesite into which a bone anchor will be installed. Cannula 1260 will besized such that the distal end of anchor loading portion 1220 with thebone anchor loaded to the end thereof may be readily passed through thecannula to the site of bone anchor implantation. In an embodiment,suture 1265, which will be used to couple tissue to the bone anchor, maybe coupled to the appropriate tissue. Suture ends 1270 may then bepassed through the cannula where they will be accessible to the surgeon.In an embodiment, a suture passer device as described below may be usedto suture the tissue and to retrieve and pass suture ends 1270 throughcannula 1275 as depicted in FIG. 40A. FIG. 40B shows an enlarged view ofthe distal end of bone anchor installer device 1200 and cannula 1260with suture ends 1270. To thread suture 1265 through a bone anchor,suture ends 1270 may be passed through loop portion 1245 of the suturepuller. Next, the surgeon pulls suture puller 1240 out of anchor holder1230 in the direction of arrow 1280 in FIGS. 40C and D, therebythreading the suture ends that are coupled to loop portion 1240 throughthe locking assembly of the bone anchor. In a final step shown in FIG.40, the surgeon removes pin 1235 from anchor holder 1230, therebyreleasing first and second holder portions 1231 and 1232 from the distalend of anchor loader portion 1220 and exposing the threaded bone anchorready for installation in a bone hole. As described above, bone anchor700 remains tethered to the distal end of anchor loading portion 1120 bytether 1260, as described above. The threaded anchor shown in FIG. 40 Fthen be passed through the cannula 1275 and installed at the operativesite.

FIG. 41 depicts a bone anchor installer 1200′ according to an alternateembodiment. Bone anchor installer 1200′ may be substantially similar thebone anchor installer 1200 already described, with the followingdifferences. In an embodiment, proximal handle portion 1210′ of anchorloading tool 1205′ may be configured such that the proximal end oftether 1260′ is made accessible to the surgeon. In an embodiment, thismay be accomplished by forming, for example, a bore (not seen here)through the length of handle portion 1210′, along its longitudinal axis.The bore may start at the proximal tip of handle portion 1210′ andextend to handle portion tip 1212,′ which couples handle portion 1210′to the proximal end of anchor loading portion 1220′. At tip 1212′ thebore may form a continuous passage with lumen 1221′ extending alonganchor loading portion 1220, through which the free end of tether 1260′is passed, as shown in FIG. 41A. End cap 1211′ may be reversiblycouplable to the proximal end of handle portion 1210′. When coupled tohandle portion 1210′ as shown, end cap 1211 ‘ may secure tether 1260’such that the tether coupling bone anchor 700′ to the distal end ofanchor loader portion 1220′ is kept taught.

In an embodiment, grasping portion 1250′ of suture passer 1240′ may besubstantially ring shaped. In an embodiment, ring portion 1250′ mayinclude clip 1251,′ which is configured to couple ring portion 1250′ tothe distal end of anchor loading portion 1220′ such that ring portion1250′ is able to slide along the longitudinal axis of anchor loadingportion 1220′ as depicted in FIG. 41B. FIG. 41B also shows a view of aportion of tether 1260′ residing within the lumen of anchor loaderportion 1220′.

FIGS. 42A-D show how a bone anchor may be tethered to anchor loadingtool 1205′ during use in accordance with one embodiment. Turning to FIG.42A, anchor loading tool 1205′ may include handle portion 1210′ that iscouplable to anchor loading portion 1220′. Handle portion 1210′ mayinclude fastening means 1214′ disposed at its proximal end, and tip1212′ and it distal end. Fastening means 1214′ may be configured suchthat cap 1211′, shown in FIG. 42B may be reversibly coupled thereto. Inan embodiment, fastening means 1214′ may include screw threads.

Anchor loading portion 1220′ may be substantially tubular in shape, withlumen 1221′ extending along its length. Anchor loading portion 1220′ mayinclude loading tip 1225′ disposed at the distal end thereof. FIG. 42 Cis an enlarged view of distal end of the anchor loading tool shown inFIG. 42B. Loading tip 1225′ may be formed with flange members 1226′which are configured to engage bone anchor 700 during use (see, e.g.,FIG. 38B).

Handle portion 1210′ may also include bore 1215′ extending fromfastening means 1214′ to tip 1212′. When the handle portion and anchorloading portions are coupled to form anchor loading tool 1205′ shown inFIG. 42B, bore 1215′ is continuous with lumen 1221′ of anchor loadingportion 1220, thereby defining a passage in which tether 1260′ isdisposed. Tether 1260′ may be made of any thread or line suitable foruse in surgical applications. Tether 1260′ may be used to engage aportion of anchor 700′ and couple it to loading tip 1225′. In anembodiment, a portion of tether 1260′ may be folded around a portion ofthe bone anchor locking assembly (see, e.g., FIG. 42C, element 1260 a).The ends of tether 1260′ pass through lumen 1221′ and bore 1215′ of theanchor loading portion and handle portion, respectively, and emerge fromfastening means 1214′ as shown in FIGS. 42B and 42D. To load the anchorto loading tip 1225′, the ends of tether 1260′ are tensioned. The tetheris kept taught by coupling cap 1211′ to fastening means 1214′.

Suture Passer Devices and the Uses Thereof

In some embodiments, a bone anchor inserter system may include a suturepasser device. Turning to FIG. 43, an embodiment of a suture passer 2000is shown. Suture passer 2000 may include a proximal end 20 I 0 havinghandle 2011 that is pivotable about joint 2012. Proximal end 2010 mayfurther include grip 2012 coupled to at least a portion of the handle.Proximal end 2010 may be configured to allow a surgeon to operate thesuture passer, including distal components thereof, during use.Likewise, grip 2013 may be configured to control one or more mechanismslocated at the distal end of the suture passer when a surgeon compressesthe grip during use. Proximal end 2010 may include a slidable engagingelement 2015 coupled to at least a portion of handle 2011. In anembodiment, engaging element 2015 may be configured to slide along thelongitudinal axis of the suture passer between a first position and asecond position (shown by the double-headed arrow in FIG. 43). Engagingelement 2015 may be operable coupled to one or more elements locateddistally to proximal end 2010 as discussed below. In an embodiment,positioning engaging element 2015 from the first position to the secondposition may allow the engagement of one or more distal elements of thesuture passer.

In an embodiment, suture passer 2000 may include a rigid or semi-rigidelongated central portion 2020 extending distally from proximal end2010. Central portion 2020 may be configured to allow the operablecoupling of one or more elements of proximal end 2010 with one or moreelements disposed at distal end 2030 of the suture passer.

In an embodiment, distal end 2030 may include a may include a tissuegrasping means 2035. A tissue grasping means 2035 may be configured toreversibly grasp a tissue. In an embodiment, tissue-grasping means 2035may include a lower jaw 2038 and an upper jaw 2037 rotatable coupled tothe lower jaw through hinged connection 2012. Rotatable couple means2012 may be configured to enable the reversible grasping of a tissuebetween the upper and lower jaws when a surgeon engages a controllingmeans (e.g., handle 2013) located at the proximal end. In an embodiment,upper jaw 2037 and lower jaw 2038 may each be configured to have atleast one suture passage 2040 extending therethrough. Suture passage2040 may be sized to allow passage of a suture segment and/or a sutureloop 2060 through the passage.

Turning now to FIG. 44, a closer view of distal end 2030 of suturepasser 2000 is shown. FIG. 44A shows tissue grasping means 2035 in aretracted state, where upper jaw 2037 is disengaged from lower jaw 2038.In this view, suture passage 2040 a passing through upper jaw 2037 andsuture passage 2040 b passing through lower jaw 2038 can be seen.

During operation, a suture length is passed through at least one of thedistally located suture passages. Advantageously, the device may beconfigured such that the suture may be passed through the suture passagein either of the jaws. FIG. 44B shows an embodiment, wherein a suture2045 is passed through suture passage 2040 b through lower jaw 2038,although it will be recognized that the suture may also be passedthrough a suture passage 2040 a without departing from the sprit orscope of the presently described embodiments. Passage of the suturethrough suture passage 2040 b occurs when upper jaw 2037 is still in aretracted state. Engagement of tissue grasping means 2035 may beoperably controlled from one or more controlling mechanisms disposed atproximal end 2010 (not shown). Engagement of tissue grasping means 2035moves upper jaw 2037 in the direction indicated by the curved arrow inFIG. 44B, and compresses suture 2045 between the upper and lower jaws.

Proceeding to FIG. 44D, distal end 2030 may further include a reversiblyextendable suture threader 2050. Suture threader 2050 may be made of arigid or semi-rigid, resilient material. Suture threader 2050 may beconfigured to be reversibly extended in the directions indicated by thedouble-headed arrow in FIG. 44D when an extending mechanism controllablefrom proximal end 2010 is engaged. In an embodiment, suture threader2050 may be configured such that, when extended, the distal portionthereof engages at least a portion of suture 2045 passing through thesuture passage, and extends the engaged portion of suture 2045 thoughone of the suture passages 2040 a 1 b to form suture loop 2060.Disengagement of suture threader 2050 allows the retraction thereof backthough suture passage 2040 a 1 b, and leaves suture loop 2060 protrudingthrough the suture passage, as depicted schematically in FIG. 44E.

In an embodiment, suture passer 2000 may include a reversibly engageablemechanical means to retrieve the suture or suture loop after is passedthough the suture passer. Engagement of the mechanical suture retrievalmeans during use may obviate the need for a separate device with whichto retrieve the suture loop, thereby improving efficiency, maximizingworking volume, and minimizing risk of contamination. In an embodiment,a mechanical suture retrieval means may include a suture captureelement. Turning to FIG. 45, a top view of distal end 2030 with sutureloop 2060 protruding from suture passage 2040 a is shown in FIG. 45A. Inan embodiment, suture capture element 2070 may be disposed at the distalportion of distal end 2030 and be moveably coupled thereto such thatsuture capture element 2070 may be moved along a longitudinal axisbetween a first retracted position 2070′ shown in FIG. 45A and a secondengaged position 2070″ shown in FIG. 45D. Suture capture element 2070may be operably coupled to engaging element 2015 so that manual movementof the engaging element in the distal element to first position 2015′shown in FIG. 45B positions suture capture element at retracted position2070′, and movement of the engaging element in the proximal direction tosecond position 2015″ shown in FIG. 45C positions the suture captureelement at engaged position 2070″ shown in FIG. 45D. When engaged,suture loop 2060 may be compressed between edge 2071 of the suturecapture element, and edge 2072 of suture passage 2040 alb allowing thefacile retrieval of the suture and/or suture loop.

While preferred illustrative embodiments of the invention are describedabove, it will be apparent to one skilled in the art that variouschanges and modifications may be made therein without departing from thespirit and scope of the invention. The appended claims are intended tocover all such changes and modifications that fall within the truespirit and scope of the invention.

In this patent, certain U.S. patents, U.S. patent applications, andother materials (e.g., articles) have been incorporated by reference.The text of such U.S. patents, U.S. patent applications, and othermaterials is, however, only incorporated by reference to the extent thatno conflict exists between such text and the other statements anddrawings set forth herein. In the event of such conflict, then any suchconflicting text in such incorporated by reference U.S. patents, U.S.patent applications, and other materials is specifically notincorporated by reference in this patent.

Further modifications and alternative embodiments of various aspects ofthe invention may be apparent to those skilled in the art in view ofthis description. Accordingly, this description is to be construed asillustrative only and is for the purpose of teaching those skilled inthe art the general manner of carrying out the invention. It is to beunderstood that the forms of the invention shown and described hereinare to be taken as the presently preferred embodiments. Elements andmaterials may be substituted for those illustrated and described herein,parts and processes may be reversed, and certain features of theinvention may be utilized independently, all as would be apparent to oneskilled in the art after having the benefit of this description to theinvention. Changes may be made in the elements described herein withoutdeparting from the spirit and scope of the invention as described in thefollowing claims. In addition, it is to be understood that featuresdescribed herein independently may, in certain embodiments, be combined.

1-13. (canceled)
 14. A method comprising: releasably attaching a boneanchor to a distal end of a loading portion; removably coupling at leasta first portion of an anchor holder to the distal end of the loadingportion; removably coupling a second portion of the anchor holder to thefirst portion; threading a suture through the bone anchor and the anchorholder; and removing the anchor holder from the distal end of theloading portion.
 15. The method of claim 14, comprising retaining thebone anchor to the loading portion with a tether.
 16. The method ofclaim 15, wherein the tether extends from the bone anchor to a proximalend of the loading portion.
 17. The method of claim 15, comprisingvarying a tension on the tether.
 18. The method of claim 15, comprisingreleasing the tether from near a proximal end of the loading portion.19. The method of claim 14, comprising delivering the bone anchor andthe loading portion to a surgical site through a cannula.
 20. The methodof claim 14, comprising the steps of: coupling a suture puller to theanchor holder and the bone anchor; coupling a suture to a distal end ofthe suture puller; and pulling the suture puller through the anchorholder and a bone anchor to couple the suture to the bone anchor. 21.The method of claim 14, comprising threading the suture through a twobar locking mechanism on the bone anchor.
 22. The method of claim 21,comprising the steps of: threading the suture between a first lockingbar and the bone anchor from the side opposite a second locking bar;threading the suture around the second locking bar on a side oppositethe bone anchor; and threading the suture back through a space betweenthe first and second locking bars and the bone anchor.
 23. The method ofclaim 14, wherein the first and second portions completely encircle thedistal end of the loading portion.
 24. The method of claim 14, whereinthe first and second portions completely encircle the bone anchor. 25.The method of claim 14, wherein the first and second portions areseparable halves of the anchor holder.
 26. The method of claim 14,further comprising coupling a suture to a first end of a suture puller;and pulling a second end of the suture puller through the anchor holderand the bone anchor.
 27. The method of claim 26, wherein the first endand the second end both protrude laterally from the anchor holder.
 28. Amethod comprising: releasably attaching a bone anchor to a distal end ofa loading portion; removably coupling an anchor holder with a cavity tothe distal end of the loading portion and the bone anchor; threading asuture through the bone anchor and the anchor holder; uncoupling theanchor holder from the loading portion while the distal end of theloading portion and the bone anchor are within the cavity; and removingthe anchor holder from the distal end of the loading portion.
 29. Themethod of claim 28, further comprising threading the suture through atwo bar locking mechanism on the bone anchor.
 30. The method of claim29, further comprising: threading the suture between a first locking barand the bone anchor from the side opposite a second locking bar;threading the suture around the second locking bar on a side oppositethe bone anchor; and threading the suture back through a space betweenthe first and second locking bars and the bone anchor.
 31. A methodcomprising: releasably attaching a bone anchor to a distal end of aloading portion; removably coupling at least a first portion of ananchor holder to the distal end of the loading portion, wherein thefirst portion defines a first inner surface of a cavity, wherein thefirst inner surface is on one side of the bone anchor; removablycoupling a second portion of the anchor holder to the first portion,wherein the second portion defines a second inner surface of the cavity,wherein the second inner surface is on another side of the bone anchor;threading a suture through the bone anchor and the anchor holder; andremoving the anchor holder from the distal end of the loading portion.32. The method of claim 31, further comprising threading the suturethrough a two bar locking mechanism on the bone anchor.
 33. The methodof claim 32, further comprising: threading the suture between a firstlocking bar and the bone anchor from the side opposite a second lockingbar; threading the suture around the second locking bar on a sideopposite the bone anchor; and threading the suture back through a spacebetween the first and second locking bars and the bone anchor.